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PHỤ LỤC I Thông tư 36/2018/TT-BYT: NGUYÊN TẮC, TIÊU CHUẨN THỰC HÀNH TỐT BẢO QUẢN THUỐC, NGUYÊN LIỆU LÀM THUỐC
| Số hiệu: | 36/2018/TT-BYT | Loại văn bản: | Thông tư |
| Nơi ban hành: | Bộ Y tế | Người ký: | Trương Quốc Cường |
| Ngày ban hành: | 22/11/2018 | Ngày hiệu lực: | 10/01/2019 |
| Ngày công báo: | 14/01/2019 | Số công báo: | Từ số 51 đến số 52 |
| Lĩnh vực: | Y tế | Tình trạng: | Còn hiệu lực |
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PHỤ LỤC I
NGUYÊN TẮC, TIÊU CHUẨN THỰC HÀNH TỐT BẢO QUẢN THUỐC, NGUYÊN LIỆU LÀM THUỐC
(Kèm theo Thông tư số 36/2018/TT-BYT ngày 22 tháng 11 năm 2018 của Bộ trưởng Bộ Y tế)
1. Thuật ngữ
Lô thuốc, nguyên liệu làm thuốc
Một số lượng thuốc, nguyên liệu làm thuốc xác định được bào chế trong một quá trình đơn lẻ hoặc chuỗi các quá trình và được coi là đồng nhất.
Số lô
Là sự kết hợp giữa các con số và/hoặc chữ cái được dùng để xác định một lô thuốc, nguyên liệu làm thuốc duy nhất.
Chuyến hàng (lô hàng)
Là số lượng thuốc, nguyên liệu làm thuốc được cung ứng trong một lần theo đơn đặt hàng cụ thể. Một chuyến hàng (lô hàng) có thể bao gồm một hay nhiều kiện hoặc thùng và có thể chứa các thuốc, nguyên liệu làm thuốc thuộc một hay nhiều lô thuốc, nguyên liệu làm thuốc khác nhau.
Ngày tái kiểm
Là ngày mà một nguyên liệu làm thuốc phải được tái kiểm tra để xác định nguyên liệu này có còn đạt tiêu chuẩn chất lượng để tiếp tục được sử dụng trong sản xuất thuốc.
Bao bì
Là vật liệu được dùng để đóng gói một thuốc, nguyên liệu làm thuốc cụ thể. Bao bì bao gồm bao bì sơ cấp, bao bì thứ cấp và bao bì chuyên chở. Bao bì được gọi là bao bì sơ cấp (hay bao bì tiếp xúc trực tiếp với thuốc, nguyên liệu làm thuốc) nếu nó tiếp xúc trực tiếp với sản phẩm. Bao bì thứ cấp là bao bì không tiếp xúc trực tiếp với sản phẩm.
Bảo quản
Là việc lưu trữ thuốc, nguyên liệu làm thuốc cho đến khi được sử dụng hết.
Biệt trữ
Là tình trạng thuốc, nguyên liệu làm thuốc được bảo quản cách ly một cách cơ học hoặc bằng biện pháp hiệu quả khác trong khi chờ quyết định cho phép nhập kho, xuất kho để bào chế, sản xuất, đóng gói, phân phối hoặc tiêu hủy.
Lấy mẫu
Là các hoạt động được thiết kế để lấy được một phần đại diện của một thuốc, nguyên liệu làm thuốc theo một quy trình thống kê thích hợp với một mục đích xác định, ví dụ như chấp thuận các lô hàng hoặc xuất xưởng lô.
Tạp nhiễm
Là sự xuất hiện không mong muốn của các tạp chất có bản chất hóa học hoặc vi sinh vật học, hoặc chất ngoại lai trong hoặc trên một nguyên liệu ban đầu, sản phẩm trung gian hoặc thành phẩm trong quá trình sản xuất, lấy mẫu, đóng gói hoặc đóng gói lại, bảo quản hoặc vận chuyển.
Nhà cung cấp
Là đơn vị cung cấp thuốc, nguyên liệu làm thuốc khi có yêu cầu. Nhà cung cấp có thể là các đại lý, nhà môi giới, nhà phân phối, nhà sản xuất hoặc kinh doanh. Trường hợp có yêu cầu, nhà cung cấp phải được chứng nhận bởi cơ quan chức năng có đủ năng lực.
Hệ thống chất lượng
Là hệ thống cơ sở hạ tầng thích hợp, bao gồm cơ cấu tổ chức, các thủ tục, các quá trình và các nguồn lực và các hành động một cách có hệ thống để bảo đảm tin tưởng chắc chắn rằng một sản phẩm (hay dịch vụ) sẽ thỏa mãn các yêu cầu đề ra về chất lượng.
Quy trình thao tác chuẩn (SOP)
Là quy trình bằng văn bản được phê duyệt, trong đó đưa ra các hướng dẫn thực hiện các hoạt động không nhất thiết liên quan đến một sản phẩm cụ thể nào đó mà mang tính chung (như quy trình vận hành thiết bị, bảo trì và làm sạch, thẩm định, vệ sinh nhà xưởng và kiểm soát môi trường, lấy mẫu và thanh tra).
2. Tổ chức và quản lý
2.1. Mỗi cơ sở cần có cơ cấu tổ chức đầy đủ, được thể hiện cụ thể bằng sơ đồ tổ chức. Sơ đồ tổ chức phải mô tả rõ ràng trách nhiệm, quyền hạn và mối quan hệ của tất cả các bộ phận (phòng, ban, tổ…) thuộc cơ sở và nhân sự chủ chốt.
2.2. Phải có bản mô tả công việc xác định rõ nhiệm vụ và trách nhiệm của từng nhân viên, được người đứng đầu cơ sở phê duyệt. Việc giao trách nhiệm cho nhân viên phải đảm bảo tránh quá tải trong công việc và phù hợp với năng lực chuyên môn. Cá nhân phải hiểu, nắm rõ nhiệm vụ và trách nhiệm được giao.
2.3. Trách nhiệm của người phụ trách chuyên môn:
a) Chịu trách nhiệm về toàn bộ các hoạt động liên quan đến chuyên môn của cơ sở, bao gồm cả việc tuân thủ các quy định quản lý liên quan đến chất lượng sản phẩm;
b) Chịu trách nhiệm phê duyệt cho nhập, xuất kho sản phẩm hoặc có thể ủy quyền cho người có trình độ chuyên môn tương đương thực hiện.
2.4. Cơ sở phải chỉ định một người có quyền hạn và trách nhiệm cụ thể và được cung cấp các nguồn lực cần thiết để đảm bảo xây dựng và duy trì hệ thống chất lượng cũng như xác định và điều chỉnh các nội dung sai lệch so với yêu cầu của hệ thống chất lượng đang áp dụng.
2.5. Các nhân sự phụ trách quản lý hành chính và kỹ thuật phải có đủ quyền hạn và nguồn lực cần thiết để thực hiện nhiệm vụ được giao, đồng thời triển khai, vận hành và duy trì hoạt động của hệ thống chất lượng trong phạm vi công việc được phân công.
3. Nhân sự
Trình độ, kinh nghiệm
3.1. Cơ sở bảo quản phải có đủ nhân viên với trình độ phù hợp để thực hiện các hoạt động liên quan đến xuất nhập, bảo quản, bốc xếp, vận chuyển, vệ sinh, bảo trì và các hoạt động khác nhằm đảm bảo chất lượng thuốc, nguyên liệu làm thuốc. Trong đó:
a) Đối với thuốc, nguyên liệu làm thuốc không phải kiểm soát đặc biệt, thủ kho phải đáp ứng các quy định sau:
- Thủ kho phải là người có trình độ, hiểu biết cần thiết về dược, về nghiệp vụ bảo quản (phương pháp bảo quản, quản lý số sách, theo dõi xuất nhập, chất lượng thuốc, nguyên liệu làm thuốc…).
- Thủ kho phải có trình độ tối thiểu là dược sĩ trung học đối với các cơ sở bảo quản thuốc, nguyên liệu làm thuốc hóa dược, vắc xin, sinh phẩm y tế.
b) Đối với thuốc, nguyên liệu làm thuốc phải kiểm soát đặc biệt: Nhân sự phải đáp ứng quy định tại các Điều 44, 45 Nghị định số 54/2017/NĐ-CP, khoản 19 Điều 4 và khoản 21, 22 Điều 5 Nghị định số 155/2018/NĐ-CP, Thông tư 20/2017/TT-BYT ngày 10/05/2017 của Bộ trưởng Bộ Y tế quy định chi tiết một số điều của Luật dược và Nghị định số 54/2017/NĐ-CP ngày 08/05/2017 của Chính phủ về thuốc và nguyên liệu làm thuốc phải kiểm soát đặc biệt và các quy định khác có liên quan.
Đào tạo
3.2. Tất cả nhân viên phải được đào tạo, cập nhật về thực hành tốt bảo quản thuốc, nguyên liệu làm thuốc, các quy định luật pháp, các quy trình thực hiện và quy định về an toàn phù hợp với vị trí công việc. Nhân viên phải được đào tạo ban đầu trước khi bắt đầu tham gia hoạt động bảo quản và phải tiếp tục được đào tạo cập nhật hàng năm phù hợp với công việc được phân công. Hiệu quả đào tạo phải được đánh giá.
3.3. Tất cả nhân viên phải được đào tạo và tuân thủ quy định giữ vệ sinh chung và vệ sinh cá nhân.
3.4. Nhân viên tham gia vào các hoạt động tiếp nhận, bảo quản, đóng gói, đóng gói lại thuốc, nguyên liệu làm thuốc kiểm soát đặc biệt; thuốc, nguyên liệu có hoạt lực mạnh (hormon sinh dục, hóa chất độc tế bào…); thuốc, nguyên liệu làm thuốc có tính nhạy cảm cao (kháng sinh nhóm betalactam…), các sản phẩm có nguy cơ gây cháy nổ (như các chất lỏng và chất rắn dễ bắt lửa, dễ cháy và các loại khí nén) phải được đào tạo cụ thể cho hoạt động này.
Yêu cầu khác
3.5. Nhân viên và cán bộ làm việc trong kho phải được kiểm tra sức khỏe định kỳ theo quy định của pháp luật. Người mắc các bệnh về đường hô hấp, hoặc có vết thương hở không được trực tiếp làm việc trong khu vực bảo quản có xử lý thuốc, nguyên liệu làm thuốc có bao bì hở.
3.6. Nhân viên làm việc trong khu vực bảo quản phải được trang bị và mặc trang phục bảo hộ phù hợp với hoạt động tại kho. Nhân viên xử lý thuốc, nguyên liệu làm thuốc có tính chất độc hại phải được trang bị trang phục bảo hộ cần thiết để đảm bảo an toàn, tránh gây hại cho người thực hiện.
4. Hệ thống chất lượng
4.1. Cơ sở phải có văn bản quy định chính sách chất lượng của cơ sở, trong đó mô tả rõ các mục tiêu tổng thể và các yêu cầu liên quan đến chất lượng. Văn bản này phải được lãnh đạo cơ sở phê duyệt và được công bố, thông tin đến toàn bộ nhân viên.
4.2. Hệ thống chất lượng phải được thiết lập và vận hành, và phải bao gồm cơ cấu tổ chức, quy trình, các quá trình, nguồn lực phù hợp và các hoạt động đồng bộ nhằm bảo đảm sản phẩm hoặc dịch vụ và các hồ sơ tài liệu của hệ thống đáp ứng các yêu cầu chất lượng đã đặt ra.
4.3. Phải có các quy định nhằm bảo đảm rằng cơ sở đăng ký, nhà sản xuất, nhà nhập khẩu, cơ quan quản lý dược/quản lý y tế và các cơ quan có thẩm quyền liên quan khác sẽ được thông báo ngay lập tức trong trường hợp thuốc, nguyên liệu làm thuốc được xác định hoặc nghi ngờ bị làm giả. Các sản phẩm này phải được biệt trữ ở khu vực có biển hiệu rõ ràng, đảm bảo an ninh và có nhãn nhận dạng đối với sản phẩm biệt trữ nhằm ngăn chặn nguy cơ tiếp tục đưa ra phân phối.
4.4. Trường hợp cơ sở bảo quản triển khai ứng dụng phương tiện điện tử trong một, một số hoặc toàn bộ các hoạt động liên quan đến tiếp nhận, bảo quản, xuất kho, kiểm tra, kiểm soát chất lượng, cơ sở cần phải có các quy trình, các phương tiện cần thiết để quản lý việc triển khai ứng dụng phương tiện điện tử tại cơ sở nhằm bảo đảm khả năng truy nguyên nguồn gốc sản phẩm và đảm bảo duy trì chất lượng sản phẩm.
4.5. Cơ sở phải có các quy định và thực hiện việc đánh giá nhà cung cấp, nhà phân phối nhằm bảo đảm thuốc, nguyên liệu làm thuốc chỉ được mua từ các cơ sở cung cấp và được bán, cấp phát cho các cơ sở đáp ứng quy định của pháp luật.
4.6. Cơ sở phải tiến hành đánh giá các nguy cơ đối với chất lượng và tính toàn vẹn của thuốc, nguyên liệu làm thuốc; trên cơ sở đó, xây dựng và triển khai các quy định, biện pháp làm giảm nhẹ hoặc loại bỏ các nguy cơ này. Cơ sở cũng phải quy định và định kỳ tiến hành rà soát, điều chỉnh hệ thống chất lượng để phát hiện, xử lý các nguy cơ mới phát sinh.
Khả năng truy nguyên nguồn gốc của thuốc, nguyên liệu làm thuốc
4.7. Cơ sở bảo quản phải có quy định nhằm bảo đảm khả năng truy nguyên trên hồ sơ đối với sản phẩm đã tiếp nhận, bảo quản, biệt trữ, xuất kho, trả về, tạo điều kiện cho việc thu hồi sản phẩm hoặc các hoạt động cần thiết khác.
4.8. Cơ sở phải có hồ sơ ghi lại thông tin về tất cả các cơ sở có liên quan đến hoạt động cung cấp, phân phối, bảo quản, sử dụng, vận chuyển thuốc, nguyên liệu làm thuốc, tối thiểu phải có tên và địa chỉ của cơ sở đó.
4.9. Cơ sở bảo quản phải quy định và có các biện pháp nhằm bảo đảm từng lô thuốc, nguyên liệu làm thuốc luôn có hồ sơ kèm theo để giúp truy nguyên nguồn gốc hoặc xác định đường đi tiếp theo của sản phẩm.
5. Nhà xưởng, trang thiết bị
5.1. Kho phải được xây dựng ở nơi cao ráo, an toàn, phải có hệ thống cống rãnh thoát nước, để đảm bảo thuốc, nguyên liệu làm thuốc tránh được ảnh hưởng của nước ngầm, mưa lớn và lũ lụt.
Kho phải có một địa chỉ xác định, có hệ thống đường giao thông công cộng hoặc giao thông nội bộ đủ rộng, đảm bảo thuận tiện cho việc vận chuyển, xuất nhập, bảo vệ, phòng cháy chữa cháy.
5.2. Nhà kho phải được thiết kế, xây dựng, trang bị, sửa chữa và bảo trì một cách hệ thống sao cho có thể bảo vệ thuốc, nguyên liệu làm thuốc tránh được các ảnh hưởng bất lợi có thể có, như: sự thay đổi nhiệt độ và độ ẩm, chất thải và mùi, các động vật, sâu bọ, côn trùng và không ảnh hưởng tới chất lượng thuốc, nguyên liệu làm thuốc.
Trần, tường, mái nhà kho phải được thiết kế, xây dựng sao cho đảm bảo sự thông thoáng, luân chuyển của không khí, vững bền chống lại các ảnh hưởng của thời tiết như nắng, mưa, bão lụt.
Nền kho phải đủ cao, phẳng, nhẵn, đủ chắc, cứng và được xử lý thích hợp để đảm bảo tránh được ảnh hưởng của nước ngầm, đảm bảo hoạt động của nhân viên làm việc trong kho, và sự di chuyển của các phương tiện cơ giới. Không được có các khe, vết nứt gãy .. là nơi tích luỹ bụi, trú ẩn của sâu bọ, côn trùng.
5.3 Kho bảo quản phải có diện tích đủ rộng để bố trí các khu vực cho các hoạt động sau:
- Tiếp nhận, kiểm nhập thuốc, nguyên liệu làm thuốc, vệ sinh và làm sạch bao bì;
- Biệt trữ (thuốc, nguyên liệu làm thuốc sau khi tiếp nhận chờ kiểm tra, kiểm soát chất lượng)
- Kiểm tra, kiểm soát chất lượng thuốc, nguyên liệu làm thuốc để nhập kho;
- Lấy mẫu nguyên liệu, xử lý dụng cụ lấy mẫu;
- Bảo quản thuốc, nguyên liệu làm thuốc;
- Bảo quản thuốc, nguyên liệu làm thuốc có yêu cầu các điều kiện bảo quản đặc biệt;
- Bảo quản thuốc, nguyên liệu làm thuốc phải kiểm soát đặc biệt hoặc phải bảo quản riêng biệt;
- Biệt trữ hàng chờ xử lý (hàng trả về, hàng thu hồi, hàng bị nghi ngờ là hàng giả, hàng nghi ngờ về chất lượng, …)
- Biệt trữ thuốc, nguyên liệu làm thuốc bị loại trước khi xử lý hủy bỏ;
- Bảo quản thuốc, nguyên liệu làm thuốc đã xuất kho chờ vận chuyển;
- Đóng gói vận chuyển và dán nhãn bao bì vận chuyển thuốc, nguyên liệu làm thuốc;
- Xuất kho;
- Bảo quản bao bì đóng gói;
- Bảo quản các thiết bị, dụng cụ phục vụ bốc, xếp, di chuyển;
- Dán nhãn phụ đối với cơ sở nhập khẩu thuốc;
- Thay trang phục, bảo quản bảo hộ lao động, văn phòng kho.
5.4. Các khu vực của kho phải có biển hiệu chỉ rõ công năng của từng khu vực, phải có diện tích và thể tích phù hợp, đủ không gian để cho phép việc phân loại, sắp xếp hàng hóa theo các chủng loại thuốc và nguyên liệu khác nhau; phân cách theo từng loại và từng lô thuốc, nguyên liệu làm thuốc, đảm bảo không khí được lưu thông đều.
Trường hợp cần thiết, có thể điều chỉnh vị trí, diện tích giữa các khu vực của kho để phù hợp với hoạt động bảo quản tại kho, nhưng phải đảm bảo duy trì điều kiện bảo quản theo quy định.
5.5. Các khu vực bảo quản phải được thiết kế hoặc điều chỉnh để bảo đảm các điều kiện bảo quản theo yêu cầu và dễ vệ sinh, làm sạch.
5.6. Khu vực lấy mẫu nguyên liệu phải được thiết kế và có hệ thống trang thiết bị đáp ứng quy định về khu vực lấy mẫu nguyên liệu làm thuốc tại thông tư của Bộ Y tế quy định về thực hành tốt sản xuất thuốc, nguyên liệu làm thuốc.
5.7. Kho bảo quản các sản phẩm có nguy cơ gây cháy nổ (như các chất lỏng và chất rắn dễ bắt lửa, dễ cháy; các loại khí nén…) phải được thiết kế, xây dựng cho việc bảo quản các sản phẩm cháy nổ theo qui định của pháp luật, phải xa các kho khác và xa khu vực nhà ở. Kho phải thông thoáng và được trang bị đèn chống cháy nổ. Các công tắc điện phải được đặt ngoài kho.
5.7. Phải trang bị các phương tiện, thiết bị phù hợp để đảm bảo các điều kiện bảo quản (ví dụ: quạt thông gió, điều hòa không khí nhiệt kế, xe chở hàng, xe nâng, ẩm kế, phòng lạnh, tủ lạnh, chỉ thị nhiệt độ vaccin, chỉ thị đông băng điện tử (Freeze Tag)..). Các thiết bị phải được kiểm tra, bảo trì, bảo dưỡng định kỳ để đảm bảo hoạt động ổn định, chính xác. Các thiết bị đo phải được hiệu chuẩn định kỳ theo quy định của pháp luật về kiểm định, hiệu chuẩn thiết bị đo.
5.8. Phải có các phương tiện phát hiện và cảnh báo tự động (như chuông, đèn và/hoặc tin nhắn) kịp thời về các sự cố, sai lệch về điều kiện bảo quản, đặc biệt đối với các thuốc có yêu cầu đặc biệt về điều kiện bảo quản (nhiệt độ, độ ẩm).
5.9. Kho phải được chiếu đủ sáng để cho phép tiến hành một cách chính xác và an toàn tất cả các hoạt động trong khu vực kho.
5.10. Có đủ các trang bị, giá, kệ để xếp hàng. Khoảng cách giữa các giá kệ, giá kệ với nền kho phải đủ rộng đảm bảo cho việc vệ sinh kho, kiểm tra đối chiếu và xếp, dỡ hàng hóa.
Các hệ thống giá kệ, pallet phải được duy trì ở tình trạng sạch sẽ, được bảo trì định kỳ và phải được mã hóa để có khả năng nhận biết theo vị trí sắp xếp hàng trong kho.
5.11. Phải có máy tính kết nối internet và thực hiện quản lý hoạt động bảo quản thuốc, nguyên liệu làm thuốc bằng phần mềm vi tính. Có cơ chế kết nối thông tin từ hoạt động nhập, xuất, phân phối thuốc, nguyên liệu làm thuốc cho khách hàng; thông tin về chất lượng thuốc, nguyên liệu làm thuốc từ nhà sản xuất và khách hàng, cũng như việc chuyển giao thông tin cho cơ quan quản lý liên quan khi được yêu cầu.
5.12. Phải có đủ các trang thiết bị phòng chữa cháy, bản hướng dẫn cần thiết cho công tác phòng chống cháy nổ như: hệ thống phòng chữa cháy tự động, hoặc các bình khí chữa cháy, thùng cát, hệ thống nước và vòi nước chữa cháy.
5.13. Các khu vực bảo quản phải khô ráo, sạch sẽ và không có rác, sâu bọ tích tụ; phải tránh ảnh hưởng từ các mùi, các yếu tố gây tạp nhiễm và ánh sáng mạnh.
5.14. Nơi rửa tay, phòng vệ sinh phải được thông gió tốt và bố trí phù hợp (cách ly với khu vực tiếp nhận, bảo quản, xử lý thuốc).
5.15. Có nội quy qui định việc ra vào khu vực kho, và phải có các biện pháp phòng ngừa, ngăn chặn việc ra vào của người không được phép.
5.16. Phải cung cấp đủ ánh sáng cho các khu vực bảo quản để có thể thực hiện tất cả các hoạt động một cách chính xác và an toàn. Không được để ánh sáng mặt trời chiếu trực tiếp vào thuốc, nguyên liệu làm thuốc.
6. Bảo quản thuốc, nguyên liệu làm thuốc
6.1. Thuốc, nguyên liệu làm thuốc phải được bảo quản trong điều kiện đảm bảo duy trì chất lượng và theo đúng quy định của pháp luật. Các lô thuốc, nguyên liệu làm thuốc phải được phân phối, cấp phát theo nguyên tắc “Hết hạn trước xuất trước” (FEFO- First Expires First Out) hoặc nguyên tắc “Nhập trước xuất trước (FIFO- First In First Out). Trong một số trường hợp cần thiết có thể không đảm bảo nguyên tắc trên nhưng phải đảm bảo tránh đưa ra phân phối các sản phẩm đã hết hạn sử dụng
6.2. Thuốc, nguyên liệu làm thuốc phải sắp xếp trên giá, kệ, tấm kê panel và được bảo quản ở vị trí cao hơn sàn nhà. Các bao, thùng thuốc, nguyên liệu làm thuốc có thể xếp chồng lên nhau nhưng phải đảm bảo không có nguy cơ đổ vỡ, hoặc gây hại tới bao, thùng thuốc bên dưới.
6.3. Bao bì thuốc phải được giữ nguyên vẹn trong suốt quá trình bảo quản. Không dùng lẫn lộn bao bì đóng gói của loại này cho loại khác.
6.4. Các khu vực giao, nhận hàng phải đảm bảo bảo vệ thuốc, nguyên liệu làm thuốc tránh khỏi tác động trực tiếp của thời tiết. Các khu vực tiếp nhận phải được thiết kế và trang bị để có thể cho phép làm sạch các kiện hàng đến, nếu cần, trước khi đưa vào bảo quản.
6.5. Phải có biện pháp về an ninh, bảo đảm không thất thoát thuốc, nguyên liệu làm thuốc phải kiểm soát đặc biệt quy định tại Nghị định 54/2017/NĐ-CP, Nghị định số 155/2018/NĐ-CP, Thông tư 20/2017/TT-BYT và quy định sau:
a) Khu vực bảo quản thuốc, nguyên liệu làm thuốc kiểm soát đặc biệt phải có biển thể hiện rõ từng loại thuốc, nguyên liệu làm thuốc kiểm soát đặc biệt tương ứng.
b) Thuốc độc, nguyên liệu độc làm thuốc phải được bao gói đảm bảo không bị thấm và rò rỉ trong quá trình vận chuyển.
6.6. Việc bảo quản thuốc, nguyên liệu có hoạt lực mạnh (hormon sinh dục, …); thuốc, nguyên liệu làm thuốc có tính nhạy cảm cao (kháng sinh nhóm betalactam…), các sản phẩm có nguy cơ gây cháy nổ (như các chất lỏng và chất rắn dễ bắt lửa, dễ cháy và các loại khí nén) ở các khu vực riêng biệt, có các biện pháp bảo đảm an toàn theo đúng quy định của các văn bản quy phạm pháp luật liên quan.
6.7. Các thuốc, nguyên liệu làm thuốc có mùi cần được bảo quản trong bao bì kín, tại khu vực riêng, tránh để mùi hấp thụ vào các thuốc, nguyên liệu làm thuốc khác.
6.8. Các thuốc nhạy cảm với ánh sáng phải được bảo quản trong bao bì kín, tránh ánh sáng, trong buồng kín hoặc trong phòng tối.
6.9. Các thuốc dễ bay hơi và các thuốc nhạy cảm với độ ẩm phải được bảo quản tại kho lạnh, bao bì đóng kín. Các chất hút ẩm mạnh phải được bảo quản trong điều kiện khô, bao bì bằng thuỷ tinh hoặc nhựa đóng kín. Nếu có thể thì nút phải được phủ paraffin.
6.10. Một số loại vắc xin dễ hỏng do đông băng (như VGB, DPT, DT, Td, uốn ván, DPT-VGB-Hib, Thương hàn, Tả…) phải đặc biệt được chú ý trong quá trình sắp xếp, bảo quản. Các vắc xin này không được sắp xếp sát vách tủ lạnh, đáy tủ lạnh hoặc gần giàn lạnh nơi phát ra luồng khí lạnh trong kho lạnh/buồng lạnh; phải để ở phía trên của tủ (đối với tủ lạnh cửa mở phía trên) hoặc ở giá giữa (đối với tủ lạnh cửa mở trước). Phải thực hiện việc kiểm soát mức độ an toàn của khu vực bảo quản bằng chỉ thị đông băng điện tử (Freeze Tag) hoặc máy ghi nhiệt độ tự động kèm thiết bị báo động.
6.11. Phải bố trí biện pháp cách ly vật lý giữa các khu vực biệt trữ trong kho. Các thuốc, nguyên liệu làm thuốc được biệt trữ ở các khu vực này phải có biển hiệu rõ ràng đối với từng tình trạng biệt trữ và chỉ những người được giao nhiệm vụ mới được phép tiếp cận khu vực này. Có thể sử dụng các phương pháp quản lý bằng điện tử để thay thế cho việc cách ly vật lý nhưng phương pháp này phải được được thẩm định, kiểm soát truy cập để đảm bảo tránh nhầm lẫn, thất thoát thuốc, nguyên liệu làm thuốc đang biệt trữ.
6.12. Phải chuyển các thuốc, nguyên liệu làm thuốc bị vỡ, hỏng ra khỏi kho bảo quản và để tách riêng.
Phải thu dọn các sản phẩm bị đổ vỡ, rò rỉ càng sớm càng tốt để tránh khả năng gây ô nhiễm, nhiễm chéo và gây nguy hại tới sản phẩm khác hoặc nhân viên làm việc tại khu vực đó. Phải có các quy trình bằng văn bản để xử lý các tình huống này.
Điều kiện bảo quản
6.13. Các điều kiện bảo quản thuốc, nguyên liệu làm thuốc phải tuân thủ theo đúng thông tin trên nhãn đã được phê duyệt hoặc công bố theo quy định.
Trừ khi có các yêu cầu đặc biệt khác (ví dụ: duy trì liên tục việc bảo quản lạnh), chỉ chấp nhận việc bảo quản nằm ngoài quy định trên trong các quãng thời gian ngắn, ví dụ khi vận chuyển cục bộ trong kho.
6.14. Hướng dẫn đối với các điều kiện bảo quản:
a) Bảo quản điều kiện thường:
Bảo quản trong môi trường khô (độ ẩm 75%), ở nhiệt độ từ 15-30°C. Trong điều kiện thời tiết khắc nghiệt, tại một số thời điểm trong ngày, nhiệt độ có thể trên 30°C nhưng không vượt quá 32°C và độ ẩm không vượt quá 80%. Phải thoáng khí, tránh ảnh hưởng từ các mùi, các yếu tố gây tạp nhiễm và ánh sáng mạnh.
Nếu trên nhãn không ghi rõ điều kiện bảo quản thì bảo quản ở điều kiện thường.
b) Điều kiện bảo quản đặc biệt: Bao gồm các trường hợp có yêu cầu bảo quản khác với bảo quản ở điều kiện thường.
c) Hướng dẫn về điều kiện bảo quản cụ thể:
Thông tin trên nhãn Yêu cầu về điều kiện bảo quản
“Không bảo quản quá 30 °C” từ +2 °C đến +30 °C “Không bảo quản quá 25 °C” từ +2 °C đến +25 °C “Không bảo quản quá 15 °C” từ +2 °C đến +15 °C “Không bảo quản quá 8 °C” từ +2 °C đến +8 °C “Không bảo quản dưới 8 °C” từ +8 °C đến +25 °C “Bảo quản lạnh” từ +2 °C đến +8 °C “Bảo quản mát” từ +8 °C đến +15 °C
“Khô”, “Tránh ẩm” không quá 75% độ ẩm tương đối trong điều kiện bảo quản thường; hoặc với điều kiện được chứa trong bao bì chống thấm đến tận tay người bệnh.
“Tránh ánh sáng” Bảo quản trong bao bì tránh ánh sáng đến tận tay người bệnh.
6.15. Các điều kiện bảo quản được kiểm tra vào những thời điểm xác định (tối thiểu 2 lần/trong ngày). Các thời điểm này được xác định trên cơ sở theo dõi liên tục điều kiện bảo quản trong kho và theo mùa. Kết quả kiểm tra phải được ghi chép và lưu hồ sơ. Hồ sơ ghi chép số liệu theo dõi về điều kiện bảo quản phải có sẵn để tra cứu.
6.16. Thiết bị theo dõi điều kiện bảo quản khi bảo quản và trong quá trình vận chuyển phải được đặt ở những khu vực/vị trí có khả năng dao động nhiều nhất được xác định trên cơ sở kết quả đánh giá độ đồng đều nhiệt độ trong kho.
Mỗi kho hoặc khu vực kho (trường hợp các khu vực kho có sự phân tách vật lý kín và có hệ thống điều hòa không khí riêng) phải được bố trí ít nhất 01 thiết bị theo dõi nhiệt độ có khả năng tự động ghi lại dữ liệu nhiệt độ đã theo dõi với tần suất ghi phù hợp (tối thiểu 30 phút/lần). Thiết bị ghi tự động phải được đặt ở vị trí có nguy cơ cao nhất dựa trên kết quả đánh giá độ đồng đều nhiệt độ.
Đối với các thuốc, nguyên liệu làm thuốc có yêu cầu điều kiện bảo quản đặc biệt (ví dụ: vắc xin, sinh phẩm), phải sử dụng các thiết bị theo dõi
điều kiện (ví dụ: nhiệt độ) liên tục trong quá trình bảo quản, vận chuyển. Việc sử dụng thiết bị theo dõi và số liệu ghi được phải được lưu lại.
6.17. Việc đánh giá độ đồng đều nhiệt độ trong kho phải được tiến hành theo nguyên tắc được ghi tại Hướng dẫn của Tổ chức Y tế thế giới về đánh giá độ đồng đều nhiệt độ của kho bảo quản (Temperature mapping of storage areas). Kết quả đánh giá độ đồng đều nhiệt độ phải cho thấy sự đồng nhất về nhiệt độ trong toàn bộ kho bảo quản.
Nhãn và bao bì
6.18. Thuốc, nguyên liệu làm thuốc phải được bảo quản trong bao bì thích hợp không gây ảnh hưởng bất lợi tới chất lượng của thuốc, nguyên liệu làm thuốc; đồng thời có khả năng bảo vệ thuốc, nguyên liệu làm thuốc khỏi các ảnh hưởng của môi trường, bao gồm cả việc chống nhiễm khuẩn.
6.19. Tất cả bao bì của thuốc, nguyên liệu làm thuốc phải có nhãn rõ ràng có đủ các nội dung theo quy định tại Thông tư số 01/2018/TT-BYT ngày 18/01/2018 của Bộ Y tế quy định việc ghi nhãn thuốc, nguyên liệu làm thuốc và tờ hướng dẫn sử dụng thuốc. Đối với bao bì không yêu cầu phải ghi nhãn theo quy định tại Thông tư này, phải thể hiện tối thiểu các thông tin sau trên bao bì: tên hàng, số lô, hạn dùng hoặc hạn kiểm tra lại, điều kiện bảo quản cụ thể.
6.20. Không được sử dụng các chữ viết tắt, tên, mã số chưa được quy định đối với các thông tin bắt buộc phải thể hiện trên nhãn bao bì nêu trên. Có thể sử dụng các chữ viết tắt, tên hoặc mã số mang tính quốc tế và/hoặc quốc gia trên nhãn bao bì chuyên chở.
Kiểm soát và luân chuyển hàng
6.21. Phải định kỳ tiến hành việc đối chiếu thuốc, nguyên liệu làm thuốc trong kho theo cách so sánh thuốc, nguyên liệu làm thuốc hiện còn và lượng thuốc, nguyên liệu làm thuốc còn tồn theo phiếu theo dõi xuất nhập thuốc, nguyên liệu làm thuốc. Trong mọi trường hợp, việc đối chiếu phải được tiến hành khi mỗi lô thuốc, nguyên liệu làm thuốc được sử dụng hết.
6.22. Tất cả các sai lệch, thất thoát khi đối chiếu số lượng thuốc, nguyên liệu làm thuốc lưu kho phải được điều tra theo quy trình cụ thể để xác định nguyên nhân (do nhầm lẫn, do xuất nhập chưa đúng, do trộm cắp thuốc, nguyên liệu làm thuốc…). Sổ sách ghi chép về các cuộc điều tra này phải được lưu giữ.
6.23. Không được cấp phát các thuốc, nguyên liệu làm thuốc có bao bì bị hư hại, không còn nguyên vẹn, mất nhãn hoặc nhãn bị rách, không rõ ràng, hoặc có nghi ngờ về chất lượng. Trường hợp này, thủ kho phải thông báo ngay với bộ phận kiểm tra chất lượng để xem xét, đánh giá. Mọi hành động tiến hành phải được ghi chép lại.
6.24. Các thùng thuốc, nguyên liệu làm thuốc đã được sử dụng một phần cần phải được đóng kín lại một cách an toàn để tránh việc rơi vãi hoặc nhiễm bẩn trong thời gian bảo quản sau này.
Kiểm soát hàng hết hạn dùng
6.25. Tất cả thuốc, nguyên liệu làm thuốc phải được kiểm tra định kỳ về hạn dùng. Phải tiến hành các biện pháp đề phòng việc cấp phát thuốc, nguyên liệu làm thuốc đã hết hạn dùng.
7. Nhập hàng
7.1. Khi nhận thuốc, nguyên liệu làm thuốc, mỗi chuyến hàng cần được kiểm tra so với lệnh/đơn mua hàng, phải xác nhận tình trạng vật lý của từng thùng hàng, ví dụ: thông tin trên nhãn, số lô, loại thuốc, nguyên liệu làm thuốc và số lượng.
7.2. Mỗi chuyến hàng phải được kiểm tra về tính đồng nhất (về ngoại quan) của các thùng thuốc, nguyên liệu làm thuốc theo từng lô thuốc, nguyên liệu làm thuốc.
7.3. Mỗi thùng thuốc, nguyên liệu làm thuốc phải được kiểm tra cẩn thận về khả năng bị nhiễm bẩn, tạp nhiễm, nhầm lẫn, bị can thiệp, bị hư hỏng và phải thực hiện việc cách ly để tiếp tục điều tra nếu có nghi ngờ về các khả năng này. Thủ kho phải thông báo ngay với bộ phận kiểm tra chất lượng để xem xét, đánh giá. Các hành động này phải được ghi chép lại.
Tất cả các thùng thuốc, nguyên liệu làm thuốc bị hư hại, mất dấu niêm phong hoặc bị nghi ngờ có tạp nhiễm thì không được nhập kho, và nếu không được huỷ bỏ ngay thì phải được bảo quản ở khu vực biệt trữ riêng, không được bán, hoặc để lẫn với các thuốc, nguyên liệu làm thuốc khác.
7.4. Trường hợp cần tiến hành lấy mẫu, việc lấy mẫu phải được thực hiện bởi người đã được đào tạo theo quy định tại Thông tư số 11/2018/TT-BYT ngày 04/5/2018 của Bộ Y tế quy định về chất lượng thuốc, nguyên liệu làm thuốc và tuân thủ nghiêm ngặt hướng dẫn lấy mẫu bằng văn bản. Các thùng thuốc, nguyên liệu làm thuốc đã được lấy mẫu phải được dán nhãn thể hiện tình trạng đã lấy mẫu.
7.5. Sau khi lấy mẫu, thuốc, nguyên liệu làm thuốc phải được biệt trữ. Phải duy trì việc phân tách theo lô trong suốt quá trình biệt trữ và bảo quản sau đó.
7.6. Thuốc, nguyên liệu làm thuốc phải được duy trì tình trạng cách ly cho đến khi có quyết định chính thức về việc chấp nhận hay loại bỏ.
7.7. Cần có biện pháp đảm bảo thuốc và nguyên liệu bị loại bỏ không được đưa ra sử dụng. Các sản phẩm này phải được bảo quản tách biệt khỏi các thuốc và nguyên liệu khác trong khi chờ hủy hoặc gửi trả nhà cung cấp.
8. Xuất hàng và vận chuyển
8.1. Việc xuất và vận chuyển thuốc, nguyên liệu làm thuốc chỉ được tiến hành sau khi nhận được lệnh xuất hàng. Việc tiếp nhận lệnh xuất hàng và việc xuất hàng phải được ghi chép vào hồ sơ.
8.2. Chỉ được xuất, cấp phát các thuốc, nguyên liệu làm thuốc đạt tiêu chuẩn chất lượng, còn trong hạn sử dụng.
8.3. Các thuốc, nguyên liệu làm thuốc đang trong quá trình biệt trữ phải được người chịu trách nhiệm về chất lượng cho phép mới được xuất kho.
8.4. Cơ sở có quyền nhập khẩu thuốc, nguyên liệu làm thuốc nhưng không được thực hiện quyền phân phối tại Việt Nam chỉ được xuất hàng và giao hàng cho cơ sở bán buôn thuốc, nguyên liệu làm thuốc tại kho bảo quản thuốc, nguyên liệu làm thuốc của cơ sở. Không được thực hiện việc vận chuyển thuốc, nguyên liệu làm thuốc, trừ hoạt động vận chuyển từ kho hải quan về kho của cơ sở hoặc giữa các kho của cơ sở.
8.5. Cơ sở bảo quản phải tiến hành kiểm soát điều kiện bảo quản trong quá trình vận chuyển thuốc, nguyên liệu làm thuốc theo đúng điều kiện bảo quản ghi trên trên nhãn thuốc, nguyên liệu làm thuốc đã được phê duyệt hoặc công bố theo quy định. Phải lưu hồ sơ theo dõi để rà soát.
8.6. Khi sử dụng đá khô trong dây chuyền lạnh, phải đặc biệt chú ý đảm bảo thuốc, nguyên liệu làm thuốc không tiếp xúc trực tiếp với đá khô, vì có thể gây ảnh hưởng xấu đến chất lượng thuốc, nguyên liệu làm thuốc, ví dụ bị đông băng.
8.7. Việc vận chuyển phải đảm bảo tính toàn vẹn của thuốc, nguyên liệu làm thuốc và điều kiện bảo quản được duy trì.
8.8. Thùng chứa bên ngoài phải cho phép bảo vệ thuốc và nguyên liệu làm thuốc khỏi các tác động từ bên ngoài và được dán nhãn rõ ràng, không tẩy xóa được.
8.9. Việc giao, nhận, vận chuyển thuốc, nguyên liệu làm thuốc phải kiểm soát đặc biệt phải theo đúng quy định của pháp luật có liên quan
9. Quy trình và hồ sơ tài liệu
Nguyên tắc chung
9.1. Các tài liệu, đặc biệt là các hướng dẫn và quy trình liên quan tới các hoạt động ảnh hưởng đến chất lượng của thuốc, nguyên liệu làm thuốc, phải được soạn thảo, hoàn thiện, rà soát và phân phối một cách cẩn trọng.
9.2. Tiêu đề, bản chất và mục đích của mỗi tài liệu phải được nêu rõ ràng. Nội dung của các tài liệu phải rõ ràng, rành mạch. Các tài liệu này phải được sắp xếp quy củ và dễ kiểm tra.
9.3. Tất cả các tài liệu đều phải được người có trách nhiệm hoàn thiện, phê duyệt, ký và ghi ngày, tháng, năm và không được thay đổi khi chưa được phép.
9.4. Hồ sơ, tài liệu phải thường xuyên được rà soát và cập nhật. Khi có một tài liệu nào đó được sửa chữa thì phải có quy trình để đảm bảo phiên bản cũ đã bị thay thế không bị sử dụng do nhầm lẫn.
9.5. Tất cả các hồ sơ, sổ sách phải luôn sẵn sàng để phục vụ việc tra cứu, rà soát và phải được bảo quản và lưu trữ bằng các phương tiện bảo đảm chúng không bị sửa chữa, tiêu hủy, gây hư hỏng và/hoặc mất mát.
9.6. Hồ sơ, sổ sách phải có đủ thông tin để tạo điều kiện cho việc truy nguyên nguồn gốc thuốc, nguyên liệu làm thuốc. Các hồ sơ, sổ sách này phải tạo điều kiện cho việc thu hồi một lô sản phẩm bất kỳ, nếu cần, cũng như điều tra các thuốc, nguyên liệu làm thuốc giả hoặc các thuốc, nguyên liệu làm thuốc có khả năng bị làm giả.
9.7. Trường hợp cơ sở xây dựng và lưu trữ hồ sơ dưới dạng điện tử thì phải có bản sao dự phòng tránh trường hợp sự cố mất dữ liệu.
9.8. Các qui trình, hướng dẫn công việc đã được phê duyệt cần phải có sẵn, treo tại các nơi dễ đọc
Các quy trình
9.9. Phải có các qui trình thao tác chuẩn đối với tất cả các hoạt động trong khu vực bảo quản thuốc, nguyên liệu làm thuốc, kể cả việc xử lý hàng hết hạn. Các văn bản này phải mô tả đầy đủ các quy trình bảo quản, đường đi của thuốc, nguyên liệu làm thuốc, bảo trì bảo dưỡng kho tàng thiết bị dùng trong bảo quản, qui định về việc ghi chép các điều kiện bảo quản, an toàn thuốc tại kho và trong quá trình vận chuyển, việc cấp phát, xuất hàng, việc lập hồ sơ, bao gồm cả các bản ghi về đơn đặt hàng của khách hàng, thuốc trả về, qui trình thu hồi và luồng thông tin trong hệ thống tổ chức khi có yêu cầu thu hồi thuốc, nguyên liệu làm thuốc.
9.10. Phải xây dựng và duy trì các quy trình về việc soạn thảo, rà soát, phê duyệt, sử dụng và kiểm soát những thay đổi của tất cả tài liệu liên quan tới quá trình bảo quản. Phải có sẵn các quy trình liên quan dù chúng là do nội bộ cơ sở xây dựng hay lấy từ nguồn bên ngoài (từ các cơ sở thực hiện dịch vụ một số hoạt động như bảo trì, hiệu chuẩn…)
9.11. Phải có quy trình nhập, xuất hàng, trong đó có cân nhắc đến bản chất của thuốc, nguyên liệu làm thuốc và các biện pháp phòng ngừa cần thiết.
9.12. Phải có quy trình đánh giá độ đồng đều điều kiện bảo quản (nhiệt độ, độ ẩm) đối với kho bảo quản, buồng lạnh, tủ lạnh, xe vận chuyển và các thiết bị, phương tiện khác có liên quan.
9.13. Phải có các quy trình đảm bảo an ninh để đề phòng tình trạng trộm cắp hoặc làm giả sản phẩm tại các cơ sở bảo quản; quy trình hủy các sản phẩm không bán được hoặc không sử dụng được và quy trình về việc lưu trữ hồ sơ.
9.14. Phải có các quy trình để xử lý các thùng chứa hàng bị hư hỏng và/hoặc đổ vỡ, rò rỉ nhằm bảo đảm loại bỏ hoàn toàn các nguy cơ có thể gây tạp nhiễm. Cần đặc biệt lưu ý các thùng hàng chứa các sản phẩm có nguy cơ độc hại.
9.15. Phải có các quy trình để điều tra và xử lý các trường hợp không tuân thủ các yêu cầu bảo quản như sai lệch nhiệt độ.
9.16. Phải có các quy trình về nhận biết, thu thập, đánh mã số, hồi cứu, bảo quản, bảo trì, loại bỏ và tiếp cận đối với tất cả các hồ sơ, tài liệu đang áp dụng.
9.17. Phải có quy trình để bảo đảm an toàn lao động, tài sản, bảo vệ môi trường và tính toàn vẹn của thuốc, nguyên liệu làm thuốc.
9.18. Phải có quy trình quy định tần suất và phương pháp vệ sinh nhà kho và khu vực bảo quản; quy trình vệ sinh khu vực lấy mẫu thuốc, nguyên liệu làm thuốc.
9.19. Phải có quy trình quy định về kiểm soát các loài vật gây hại (côn trùng, chuột bọ…). Các chất dùng để diệt các loài vật gây hại phải không có nguy cơ gây ô nhiễm cho thuốc, nguyên liệu làm thuốc.
Hồ sơ tài liệu
9.20. Phải có hồ sơ ghi chép đối với tất cả các hoạt động trong khu vực bảo quản thuốc, nguyên liệu làm thuốc, kể cả việc xử lý hàng hết hạn.
9.21. Phải có hồ sơ chi tiết thể hiện tất cả các lần nhận, xuất của thuốc, nguyên liệu làm thuốc; các hồ sơ này phải được sắp xếp theo một hệ thống xác định, thuận lợi cho việc tra cứu, ví dụ: theo số lô nội bộ.
9.22. Hồ sơ cho mỗi chuyến hàng nhập phải tối thiểu bao gồm mô tả về hàng hóa, chất lượng, số lượng, nhà sản xuất, số lô gốc của nhà sản xuất, nhà cung cấp, ngày nhận, số lô nội bộ và hạn dùng.
9.23. Hồ sơ xuất hàng phải bao gồm tối thiểu các thông tin sau đây:
- Ngày, tháng, năm xuất kho;
- Tên và địa chỉ đầy đủ của đơn vị chịu trách nhiệm vận chuyển, số điện thoại và tên của người liên hệ;
- Tên và địa chỉ đầy đủ của đơn vị tiếp nhận;
- Mô tả về thuốc, nguyên liệu làm thuốc (ví dụ: tên, dạng bào chế, hàm lượng, số lô và số lượng);
- Các điều kiện vận chuyển và bảo quản được áp dụng.
9.24. Phải có hồ sơ bằng văn bản viết hoặc điện tử đối với mỗi thuốc hoặc nguyên liệu làm thuốc được bảo quản, trong đó chỉ ra điều kiện bảo quản được khuyến cáo, cảnh báo cần lưu ý và hạn tái kiểm (nếu có). Phải đáp ứng các quy định của pháp luật liên quan đến nhãn và bao bì.
9.25. Có hồ sơ sổ sách riêng đối với trường hợp có bảo quản thuốc, nguyên liệu làm thuốc phải kiểm soát đặc biệt theo quy định tại Nghị định 54/2017/NĐ-CP ngày 08/5/2017, Nghị định số 155/2018/NĐ-CP ngày 12/11/2018 và Thông tư số 20/2017/TT-BYT và văn bản quy phạm pháp luật khác có liên quan.
Lưu trữ, bảo quản hồ sơ
9.26. Phải tuân thủ quy định pháp luật về thời gian bảo quản hồ sơ đối với từng thuốc, nguyên liệu là thuốc. Trường hợp không có quy định, hồ sơ phải được lưu trữ tối thiểu thêm 01 (một) năm kể từ thời điểm hết hạn của lô thuốc, nguyên liệu làm thuốc.
10. Hàng trả về
10.1. Thuốc, nguyên liệu làm thuốc trả về, bao gồm cả thuốc, nguyên liệu làm thuốc bị thu hồi, phải được xử lý theo quy trình đã được phê duyệt và lưu hồ sơ.
10.2. Tất cả thuốc, nguyên liệu làm thuốc trả về phải được bảo quản trong khu vực biệt trữ và chỉ được đưa trở lại khu bảo quản thường sau khi được sự phê duyệt bởi người có thẩm quyền căn cứ trên các đánh giá thoả đáng về chất lượng, đảm bảo an toàn cho người sử dụng.
10.3. Bất cứ lô thuốc, nguyên liệu làm thuốc nào khi tái cấp phát phải được nhận dạng và ghi hồ sơ.
10.4. Hồ sơ liên quan đến tất cả các thuốc, nguyên liệu làm thuốc bị trả về, bị từ chối tiếp nhận và/hoặc bị tiêu hủy phải được lưu giữ trong một khoảng thời gian xác định.
10.5. Tất cả các thuốc, nguyên liệu làm thuốc trả về, sau khi được bộ phận bảo đảm chất lượng đánh giá là không đảm bảo chất lượng, không đảm bảo an toàn cho người sử dụng phải được xử lý theo qui định của pháp luật.
11. Sản phẩm bị thu hồi
11.1. Phải có quy trình thu hồi từ thị trường một cách kịp thời và hiệu quả đối với thuốc, nguyên liệu làm thuốc khi phát hiện có lỗi hoặc nghi ngờ có lỗi hoặc bị giả mạo, và có người được giao trách nhiệm thu hồi. Hệ thống này phải tuân thủ quy định pháp luật. Quy trình này phải được kiểm tra và cập nhật thường xuyên khi cần.
11.2. Tất cả các thuốc, nguyên liệu bị thu hồi phải được bảo quản ở khu vực bảo đảm an ninh, đáp ứng điều kiện bảo quản của hàng hóa và cách ly để chờ các hoạt động xử lý tiếp theo. Đối với những nơi không có điều kiện cách ly sản phẩm bị thu hồi thì sản phẩm đó phải được bao gói an toàn, ghi nhãn rõ ràng và có sổ sách ghi chép phù hợp kèm theo.
11.3. Các điều kiện bảo quản đặc biệt đối với thuốc, nguyên liệu làm thuốc bị thu hồi phải được duy trì trong suốt quá trình bảo quản và chờ vận chuyển cho đến khi có quyết định cuối cùng về việc xử lý sản phẩm bị nghi ngờ.
11.4. Tất cả các hồ sơ, sổ sách phải sẵn sàng để cung cấp cho người chịu trách nhiệm đối với việc thu hồi. Các hồ sơ, sổ sách này phải có đầy đủ các thông tin về các thuốc, nguyên liệu làm thuốc đã cấp phát (kể cả thuốc, nguyên liệu làm thuốc được xuất khẩu).
12. Tự thanh tra
12.1. Hệ thống chất lượng phải bao gồm hoạt động tự thanh tra. Hoạt động tự thanh tra phải được thực hiện để theo dõi việc triển khai và tuân thủ các nguyên tắc GSP và theo dõi các hành động khắc phục và phòng ngừa, nếu có.
12.2. Việc tự thanh tra phải do người có chuyên môn và có thẩm quyền tiến hành một cách độc lập và chi tiết.
12.3. Kết quả của tất cả các đợt tự thanh tra phải được ghi chép. Biên bản tự thanh tra phải bao gồm tất cả các điểm phát hiện được trong đợt tự thanh tra và các đề xuất về biện pháp khắc phục, nếu có. Cần có chương trình theo dõi một cách hiệu quả. Người quản lý phải đánh giá biên bản tự thanh tra và các hồ sơ về bất kỳ hành động khắc phục nào đã được thực hiện.
|
THE MINISTRY OF HEALTH |
THE SOCIALIST REPUBLIC OF VIETNAM |
|
No. 36/2018/TT-BYT |
Hanoi, November 22, 2018 |
CIRCULAR
GOOD STORAGE PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS
Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;
Pursuant to the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for implementation of the Law on Pharmacy;
Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health;
Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;
At the request of the General Director of the Drug Administration of Vietnam,
The Minister of Health hereby promulgates a Circular on Good Storage Practices for medicinal products and materials.
GENERAL PROVISIONS
This Circular provides for application and promulgation of Good Storage Practices for medicinal products and medicinal materials (hereinafter referred to as “GSP”) and inspection of GSP compliance.
For the purposes of this Circular, the terms below shall be construed as follows:
1. “storage of medicinal products and medicinal materials” means the storage aimed at ensuring safety and quality of medicinal products and materials, including the use and maintenance of a complete system of documentation serving storage, export and import of medicinal products and medicinal materials (hereinafter referred to as “materials”) at the warehousing site.
2. “Good Storage Practices” (GSP) means a set of requirements for storage of medicinal products and materials to ensure and maintain safety and quality of medicinal products and materials by means of adequate control throughout the storage thereof.
3. “deficiency” means a deviation from GSP requirements or regulations of the law on pharmacy.
4. “storage facility” means a facility that stores medicinal products and materials and includes importers of medicinal products and materials; exporters of medicinal products and materials; providers of medicinal product and medicinal material storage services; pharmacy establishments not required to obtain Certificates of eligibility for pharmacy business that allows storage of medicinal products (major storage facilities for storage of medicinal products under national health program and of the military; storage facilities for storage of medicinal products under national Expanded Program on Immunization and of health facilities and other non-commercial facilities whose operation involves storage of medicinal products and materials)
5. “GSP” stands for Good Storage Practices.
6. “WHO” stands for World Health Organization.
PROMULGATION OF GSP
Article 3. Documents about GSP requirements
1. Promulgate GSP requirements in the Appendix I hereof according to WHO guidelines and updated documents specified in Clause 5 of this Article.
2. Promulgate requirements of GSP for herbal medicinal materials and traditional ingredients that are specified in the Appendix I hereof.
3. Promulgate GSP requirements specified in the Appendix III hereof, applicable to pharmacy establishments not required to obtain Certificates of eligibility for pharmacy business that allows storage of medicinal products, except health facilities specified in Clause 4 of this Article.
4. Promulgate GSP requirements that are specified in the Appendix IV hereof, applicable to health facilities.
5. In the cases where WHO makes any revision to GSP requirements mentioned in the Appendix I hereof, within 06 months from the date on which updated documents are published on WHO website, the Drug Administration of Vietnam shall translate them and publish the revisions on the web portal of the Ministry of Health and websites of the Drug Administration of Vietnam and Traditional Medicine Administration of Vietnam.
Article 4. Application of GSP requirements
1. Importers and exporters of medicinal products and materials and providers of medicinal product and medicinal material storage services (except for importers and exporters of herbal medicinal materials and traditional ingredients and providers of medicinal product and traditional ingredient storage services) shall apply GSP requirements specified in Appendix I hereof and updated documents specified in Clause 5 Article 3 hereof.
2. Importers and exporters of herbal medicinal materials and traditional ingredients and providers of medicinal product and traditional ingredient storage services shall apply GSP requirements specified in Appendix II hereof.
3. Major storage facilities for storage of medicinal products under national health program and of the military; storage facilities for storage of medicinal products under national Expanded Program on Immunization at central, regional or provincial level shall apply GSP requirements specified in Appendix III hereof.
4. Medicinal product warehouses (except for warehouses of herbal medicinal materials and traditional ingredients), vaccination clinics, storage facilities for storage of vaccines under national Expanded Program on Immunization in districts shall apply GSP requirements specified in Appendix IV hereof.
5. Warehouses of herbal medicinal materials and traditional ingredients of health facilities shall apply GSP requirements specified in Appendix II hereof (except contents specified in Point 3.2 of this Appendix).
6. Establishments that are entitled to import but are not entitled to distribute medicinal products and materials in Vietnam shall apply and comply with GSP requirements specified in Appendix I hereof (except regulations on transport for the purposes of distribution of medicinal products and materials specified in Clause 8 of Appendix I) and updated documents specified in Clause 5 Article 3 of this Circular.
7. Medicinal product and material storage facilities shall apply updated GSP documents specified in Clause 1 of this Article within:
a) 12 months in case of any change of warehouses or equipment serving storage of medicinal products and materials, from the date on which updated documents are published on the website of the Ministry of Health and web portals of the Drug Administration of Vietnam and Traditional Medicine Administration of Vietnam;
b) 06 months in case of updates other than those specified in Point a of this Clause, from the date on which updated documents are published on the website of the Ministry of Health and web portals of the Drug Administration of Vietnam and Traditional Medicine Administration of Vietnam.
INSPECTION OF GSP COMPLIANCE
Article 5. Documents used as basis for inspection of GSP compliance
1. Documents used as basis for inspection of GSP compliance by a storage facility are those included in its application for certificate of eligibility for pharmacy business (the establishment is not required to submit these documents because they have been submitted when it applies for the certificate of eligibility for pharmacy business) prescribed in Article 38 of the Law on Pharmacy and Article 32 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for the implementation of the Law on Pharmacy (hereinafter referred to as “the Decree No. 54/2017/ND-CP”). Storage facilities for storage of special-controlled medicinal products must have the documents prescribed in Article 38 of the Law on Pharmacy and Clause 31 Article 5 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health (hereinafter referred to as “the Decree No. 155/2018/ND-CP”).
Technical documents about a storage facility shall be prepared in accordance with guidelines for the site master file provided in the Appendix VI hereof or the site master file that is updated in the case of change of scope of operation.
2. If a storage facility applies for both certificate of GSP compliance and certificate of eligibility for pharmacy business, this content must be clearly specified in its application form for certificate of eligibility for pharmacy business.
Article 6. Sequence of inspection of GSP compliance
1. Receipt of applications:
The storage facility shall submit an application, which includes the documents specified in Article 5 herein, accompanied by the application fees in accordance with regulations of the Minister of Finance and conditions for storage of medicinal products, medicinal materials and herbal medicinal materials to:
a) the Traditional Medicine Administration of Vietnam if the storage facility is an importer, exporter or storage service provider that applies for the certificate for eligibility for pharmacy business that only allows trading in herbal medicinal materials, traditional medicinal products and traditional ingredients at the time of submission;
b) the Drug Administration of Vietnam if the storage facility is an importer, exporter or storage service provider that applies for the certificate for eligibility for pharmacy business that allows trading in chemical medicinal products, vaccines, biologicals, herbal medicinal products and medicinal materials (excluding herbal medicinal materials);
c) the Drug Administration of Vietnam if the storage facility is an importer, exporter or storage service provider that applies for the certificate for eligibility for pharmacy business that allows trading in both one of the medicinal products and materials specified in Point a of this Clause and one of the medicinal products and materials specified in Point b of this Clause at the time of submission.
2. Sequence of receiving and processing applications is prescribed in Clauses 2 and 5 Article 33 of the Decree No. 54/2017/ND-CP and Clause 12 Article 5 of the Decree No. 155/2018/ND-CP.
3. Within 05 days from the receipt of the satisfactory application, the receiving authority shall establish an inspectorate and send the storage facility the decision on inspectorate establishment specifying expected date of the site inspection.
Within 15 days from the date of issuing the decision, the inspectorate shall carry out a site inspection of the storage facility.
Article 7. Procedures for inspection and classification of GSP compliance
1. Principles of using GSP documents for inspection of GSP compliance:
GSP specified in Clauses 1 and 2 Article 4 of this Circular is applicable to the storage of medicinal products and materials by the applicant for the certificate of eligibility for pharmacy business.
2. Inspection procedures:
a) Step 1. The inspectorate shall publish the decision on inspectorate establishment, purposes, contents and plan for the inspection at the storage facility;
b) Step 2. The storage facility shall make a brief introduction of its organizational structure, personnel and implementation or application of GSP, or specific contents in conformity with the inspected contents;
c) Step 3. The inspectorate shall carry out a site inspection of the application of GSP at the storage facility;
d) Step 4. The inspectorate shall have a talk with the storage facility about deficiencies found during the inspection (if any) and assess the level of each deficiency; discuss with the storage facility in case the it does not agree with the inspectorate about the assessment of each deficiency or level of GSP compliance;
dd) Step 5. An inspection record is prepared and signed as follows:
After the site inspection is done, the inspectorate shall make an inspection record using the Form No. 03 in the Appendix VII hereof. It shall clearly specify members of the inspectorate and the storage facility, location, date and scope of the inspection and disagreements (if any) between the inspectorate and the storage facility.
It shall be signed by the head of the storage facility and chief of the inspectorate
The record shall be made into 03 copies, among which one is kept by the storage facility and the others are kept by the receiving authority.
e) Step 6. The inspection record is completed as follows:
The inspectorate shall make a GSP inspection report using the Form No. 04 in the Appendix X hereof, list, analyze and classify deficiencies that need to be rectified by the storage facility, make a comparison of corresponding regulations specified in legal documents and GSP, and assess the level of GSP compliance. The deficiency classification and assessment of level of GSP compliance are prescribed in the Appendix V hereof.
3. Level of GSP compliance:
The inspection of storage facility's compliance with GSP requirements specified in the Appendix V hereof shall be carried out according to the following 03 levels:
a) GSP level 1 storage facility;
b) GSP level 2 storage facility;
c) GSP level 3 storage facility.
Article 8. Processing results of inspection of GSP compliance
1. If the GSP inspection report indicates that the storage facility complies with GSP requirements at level 1 as prescribed in Point a Clause 3 Article 7 of this Circular:
Within 10 days from the date of signing the inspection record, the receiving authority shall request the Minister of Health to issue the certificate of eligibility for pharmacy business and issue the Certificate of GSP compliance according to Form No. 05 in the Appendix VII hereof if the storage facility applies for both certificate of GSP compliance and certificate of eligibility for pharmacy business.
2. If the GSP inspection report indicates that the storage facility complies with GSP requirements at level 2 as prescribed in Point a Clause 3 Article 7 of this Circular:
a) Within 05 days from the date of signing the inspection record, the receiving authority shall send the GSP inspection report to the storage facility as prescribed in Point b Clause 6 Article 33 of the Decree No. 54/2017/ND-CP.
b) Upon completion of deficiency rectification, the storage facility shall submit a rectification report including a plan and evidences (such as documents, images, videos, certificates or other documentary evidences) for rectification of deficiencies specified in the GSP inspection report;
c) Within 20 days from the receipt of the rectification report, the receiving authority shall assess result of deficiency rectification by the storage facility and conclude the level of its GSP compliance. To be specific:
- If the result of deficiency rectification makes the storage facility comply with GSP requirements, the receiving authority shall request the Minister of Health to issue the certificate of eligibility for pharmacy business and the certificate of GSP compliance according to the Form No. 05 in the Appendix VII hereof if the storage facility applies for both certificate of GSP compliance and certificate of eligibility for pharmacy business;
- If the result of deficiency rectification shows that the storage facility still fails to comply with GSP requirements, the receiving authority shall respond and provide explanation in writing.
d) Within 06 months from the date on which additional documents are requested in writing by the receiving authority, the storage facility shall submit them as requested. If the storage facility fails to satisfy such request by the aforementioned deadline or the application is not satisfactory within 12 months from the first time it is submitted, the application will be rejected.
3. If the GSP inspection report indicates that the storage facility complies with GSP requirements at level 3 as prescribed in Point c Clause 3 Article 7 of this Circular:
Within 05 days from the date of signing the inspection record, the receiving authority shall send the storage facility a notification of its failure to comply with GSP requirements enclosed with the GSP inspection report and shall not issue the certificate of eligibility for pharmacy business.
4. In the cases where the storage facility does not agree with the deficiency stated by the inspectorate, within 30 days from the date on which the inspectorate sends GSP inspection report or rectification report, the storage facility shall submit a written recommendation enclosed with evidences (such as documents, images, videos and certificates) related to such deficiency to the receiving authority.
Within 10 days from the receipt of the written recommendation, the receiving authority shall review GSP inspection report and written recommendation submitted by the storage facility, if necessary, consult relevant exports and respond to the storage facility in writing. The written response must clearly specify agreements and disagreements with the written recommendation submitted by the storage facility and reasons for disagreements. The abovementioned length of time shall not add to the time limit for inspection.
5. Within 05 days from the date of issuing the certificate of eligibility for pharmacy business, the receiving authority shall publish the following information on its website and web portal of the Ministry of Health:
a) Name and address of the storage facility;
b) Full name of the chief pharmacist and number of his/her pharmacy practicing certificate;
c) Number of the certificate of eligibility for pharmacy business and Certificate of GSP compliance (if any);
d) Expiry date of inspection of GSP compliance;
dd) Scope of operation of the storage facility.
INSPECTION OF GSP COMPLIANCE AND MAINTENANCE THEREOF
Article 9. Periodic inspection of GSP compliance
1. GSP compliance by a storage facility shall be periodically inspected every 03 year from the date of signing the previous inspection record (except unexpected inspections or audits by the Ministry of Health or the Provincial Department of Health).
2. In November, every receiving authority shall publish the plan for periodic inspection of GSP compliance by storage facilities in the succeeding year on its website and send it to storage facilities that are mentioned in the plan. Regarding the storage facility specified in Point c Clause 1 Article 6 of this Circular, the Drug Administration of Vietnam shall publish and implement the periodic inspection plan, except in the cases where the storage facility applies for a particular inspection.
3. At least 30 days prior to the date of carrying out periodic inspection of GSP compliance according to the published plan, the storage facility shall submit a report on its import or export of medicinal products and materials or provision of medicinal product and medicinal material storage services and GSP compliance (hereinafter referred to as “operation and GSP compliance report”) according to the Form No. 2 in the Appendix VII hereof enclosed with updated technical documents about infrastructure, technologies and personnel of the storage facility (in case any change is made) to the receiving authority.
E.g.: If the estimated date of periodic inspection of the storage facility A is on August 18, 2018, the storage facility A is required to submit an operation and GSP compliance report to the receiving authority by July 18, 2018.
4. If the storage facility fails to submit the operation and GSP compliance report within the time limit prescribed in Clause 3 of this Article, within 15 days from the deadline for submission of the report, the receiving authority shall request the storage facility in writing to submit the operation and GSP compliance report as prescribed.
5. Within 45 days from the date on which the operation and GSP compliance report is requested in writing by the receiving authority, the storage facility shall submit the report enclosed with a written explanation for its delay in submission. By the aforementioned deadline, if the storage facility fails to submit the report, the receiving authority shall carry out an unexpected inspection and audit of GSP compliance by the storage facility as prescribed in Article 12 of this Circular.
6. After submitting the operation and GSP compliance report within the prescribed time limit, the storage facility is entitled to keep storing medicinal products and materials within the scope specified in the certificate for eligibility for pharmacy business until the result of periodic inspection of GSP compliance is available and shall ensure its maintenance of GSP compliance.
7. Sequence of inspecting and procedures for inspecting and classifying results of inspection of GSP compliance are prescribed in Articles 6 and 7 of this Circular.
Article 10. Processing of results of periodic inspection of GSP compliance
1. If the GSP inspection report indicates that the storage facility complies with GSP requirements at level 1 as prescribed in Point a Clause 3 Article 7 of this Circular:
Within 10 days from the date of signing the inspection record, the receiving authority shall update information about the maintenance of GSP compliance by the storage facility on its website and web portal of the Ministry of Health as prescribed in Clause 5 Article 8 of this Circular and issue the certificate of GSP compliance according to Form No. 05 in the Appendix VII hereof if the storage facility applies for the certificate of GSP compliance.
2. If the GSP inspection report indicates that the storage facility complies with GSP requirements at level 2 as prescribed in Point b Clause 3 Article 7 of this Circular:
a) Within 05 working days from the date of signing the inspection record, the receiving authority shall send the GSP inspection report to the storage facility so that it can rectify deficiencies and send a rectification report to the receiving authority;
b) Within 45 days from the date on which the receiving authority sends the GSP inspection report, the storage facility shall submit a rectification report including a plan and evidences (such as documents, images, videos, certificates or other documentary evidences) for rectification of deficiencies specified in the GSP inspection report;
c) Within 20 days from the receipt of the rectification report, the receiving authority shall assess result of deficiency rectification by the storage facility and conclude the level of its GSP compliance. To be specific:
- If the result of deficiency rectification makes the storage facility comply with GSP requirements, the receiving authority shall update information about the maintenance of GSP compliance by the storage facility on its website and web portal of the Ministry of Health as prescribed in Clause 5 Article 8 of this Circular and issue the Certificate of GSP compliance according to Form No. 05 in the Appendix VII hereof if the storage facility applies for the certificate of GSP compliance;
- If the result of deficiency rectification shows that the storage facility still fails to comply with GSP requirements, the receiving authority shall request the storage facility in writing to take more corrective actions against deficiencies and submit an additional report. The storage facility shall have 45 days from the receipt of the written request to complete corrective actions and send report thereof as requested.
d) Within 90 days from the date of signing the inspection record, if the storage facility fails to submit the rectification report or still fails to comply with GSP requirements after rectifying deficiencies, the receiving authority shall send a notification of failure to comply with GSP requirements and impose one or some measures prescribed in Points and b Clause 3 of this Clause depending on the nature and level of non-compliance with GSP requirements.
3. If the GSP inspection report indicates that the storage facility complies with GSP requirements at level 3 as prescribed in Point c Clause 3 Article 7 of this Circular:
Within 05 working days from the date of signing the inspection record, according to the assessment of risks of deficiencies in the quality of medicinal products and materials and medicinal product user safety, the receiving authority shall send a notification of failure to comply with GSP requirements enclosed with a GSP inspection report. Depending on the nature and level of non-compliance with GSP requirements, the receiving authority shall impose one or some of the following measures:
a) Impose penalties for administrative violations in accordance with regulations of the Law on penalties for administrative violations;
b) Request the Minister of Health to issue a decision on revocation of the certificate of eligibility for pharmacy business as prescribed in Clause 2 Article 40 of the Law on Pharmacy and revoke the certificate of GSP compliance (if any).
c) If the storage facility is ineligible for one or several business activities specified in its certificate of eligibility for pharmacy business, the receiving authority shall:
- request the Minister of Health to issue a decision on revocation of the certificate of eligibility for pharmacy business to remove the business activity for which the storage facility is ineligible and issue a new certificate of eligibility for pharmacy business which is conformable with the business activity for which the storage facility is eligible.
- issue the certificate of GSP compliance which is conformable with the business activity for which the storage facility is eligible if it so wishes.
4. Within 05 working days from the date of concluding that the storage facility maintains its compliance with GSP requirements or issuing the decision on revocation of the issued certificate of eligibility for pharmacy business because of the storage facility’s failure to maintain GSP compliance, the receiving authority shall update GSP compliance status on its website as prescribed in Clause 5 Article 8 of this Circular if the storage facility complies with GSP requirements or information about the revocation of the certificate of eligibility for pharmacy business or Certificate of GSP compliance (if any) if the storage facility fails to maintain its GSP compliance.
5. If it is concluded that a sample of medicinal product or medicinal material collected by the inspectorate during the inspection violates quality regulations, the receiving authority shall handle it in accordance with applicable regulations.
Article 11. Control of changes
1. After making any changes, the storage facility shall apply for the certificate of eligibility for pharmacy business or submit a report on its changes using the Form No. 06 in the Appendix VII hereof if:
a) making one of the changes specified in Point b Clause 1 Article 36 of the Law on Pharmacy; or
b) changing the location of a warehouse at the same business location; or
c) opening a new warehouse at the same business location; or
d) expanding existing warehouse; or
dd) repairing or having significant changes in structure and floor plan of a warehouse; or
e) changing auxiliary system or principle of designing and operating utility systems, thereby affecting storage requirements and conditions.
2. In case of the change prescribed in Point a Clause 1 of this Article, the storage facility shall submit an application for the certificate of eligibility for pharmacy business as prescribed in Clauses 2 and 4 Article 38 of the Law on Pharmacy.
Sequence of inspecting, classifying and processing the result of inspection of GSP compliance is specified in Articles 6, 7 and 8 of this Circular.
3. In case of one of the changes prescribed in Point b or c Clause 1 of this Article, the storage facility is required to submit a report on its changes, accompanied by relevant technical documents, to the receiving authority.
a) The receiving authority shall carry out a site inspection at the storage facility. If the storage facility complies with GSP requirements, the receiving authority shall grant a written consent to its changes;
b) Sequence of inspecting, classifying and processing the result of inspection of GSP compliance in case of the change specified in Point b Clause 1 of this Article is prescribed in Articles 6, 7 and 10 of this Circular;
c) Sequence of inspecting, classifying and processing the result of inspection of GSP compliance in case of the change specified in Point c Clause 1 of this Article is prescribed in Articles 6, 7 and 8 of this Circular.
4. In case of one of the changes prescribed in Point d, dd or e Clause 1 of this Article, the storage facility is required to submit a report on its changes, accompanied by relevant technical documents, to the receiving authority. The receiving authority shall assess the storage facility's report on changes.
a) Within 10 days from the receipt of the report on changes, the receiving authority shall notify the storage facility in writing of approval for its changes if they meet requirements or issue a notification of deficiencies that need rectifying if its changes fail to meet with requirements;
b) Within 45 days from the receipt of the notification, the storage facility shall complete deficiency rectification and send a rectification report enclosed with documentary evidences (such as documents, images, videos, certificates and other documentary evidences) for completion of rectification of deficiencies specified in the notification;
c) Within 10 days from the receipt of the rectification report enclosed with documentary evidences (such as documents, images, videos, certificates and other documentary evidences), the receiving authority shall assess result of deficiency rectification by the storage facility and conclude the level of its GSP compliance. To be specific:
- If the result of deficiency rectification makes the storage facility comply with GSP requirements, the receiving authority shall notify the storage facility in writing of approval for its changes;
- If the result of deficiency rectification shows the storage facility still fails to comply with GSP requirements, the receiving authority shall carry out an unexpected inspection and process inspection result as prescribed in Article 12 of this Circular.
Article 12. Unexpected inspection of GSP compliance or audit GSP compliance and maintenance thereof
1. Audit of GSP compliance and maintenance thereof by storage facilities shall be conducted as prescribed by law.
2. An unexpected inspection of GSP compliance and maintenance thereof shall be carried out at the storage facility in one of the following cases:
a) The result of deficiency rectification by the storage facility shows it still fails to comply with GSP requirements according to Sub-point 2 Point c Clause 4 Article 11 of this Circular;
b) The storage facility that complies with GSP requirements at level 2 or level 3 according to Points b and c Clause 3 Article 7 of this Circular shall undergo an unexpected inspection at least once within 03 (three) years from the end of the previous inspection;
c) The inspecting authority concludes that the storage authority seriously violates GSP;
d) There is any complaint or denunciation that the storage facility seriously violates GSP;
e) The storage facility fails to submit the operation and GSP compliance report according to Clause 5 Article 9 of this Circular.
3. The head of the receiving authority shall decide on members of the inspectorate as prescribed in Article 15 of this Circular.
4. Sequence of conducting unexpected inspections at a storage facility is mentioned in Article 7 of this Circular.
5. Results of unexpected inspections or audits conducted at a storage facility shall be processed as prescribed in Article 10 of this Circular.
GSP COMPLIANCE BY PHARMACY ESTABLISHMENTS NOT REQUIRED TO OBTAIN CERTIFICATES OF ELIGIBILITY FOR PHARMACY BUSINESS
Article 13. GSP compliance by health facilities, vaccination clinics and storage facilities for storage of vaccines under national Expanded Program on Immunization in districts and provinces
1. Every health facility, vaccination clinic and storage facility for storage of vaccines under national Expanded Program on Immunization (hereinafter referred to as “the facility”) in districts and provinces shall comply with GSP requirements as prescribed in Clauses 3, 4 and 5 Article 4 of this Circular and send a notification of GSP compliance according to the Form No. 01 in the Appendix VII hereof to the Department of Health of the province or central-affiliated city (hereinafter referred to as “the Department of Health”) where the facility operates.
2. Within 05 days from the receipt of the notification of GSP compliance, the Department of Health shall publish the following information on its website:
a) Name and address of the facility sending the notification of GSP compliance;
b) Date of notifying GSP compliance;
c) Scope of operation of the facility sending the notification of GSP compliance.
3. The Department of Health shall inspect and audit GSP compliance by the facility as prescribed in Article 15 of this Circular.
Article 14. GSP compliance by major storage facilities for storage of medicinal products under national health program and of the military and storage facilities for storage of vaccines medicinal products under national Expanded Program on Immunization at central, regional or provincial level
1. Every major storage facility for storage of medicinal products under national health program and of the military and storage facility for storage of vaccines medicinal products under national Expanded Program on Immunization at central, regional or provincial level (hereinafter referred to as “the facility”) shall comply with GSP requirements as prescribed in Clauses 3, 4 and 5 Article 4 of this Circular and send a notification of GSP compliance according to the Form No. 01 in the Appendix VII hereof to the receiving authority specified in Clause 1 Article 6 of this Circular. The facility is allowed to storage medicinal products from the date on which the notification is sent.
2. Within 05 days from the receipt of the notification of GSP compliance, the receiving authority shall publish the following information on its website:
a) Name and address of the facility sending the notification of GSP compliance;
b) Date of notifying GSP compliance;
c) Scope of operation of the facility sending the notification of GSP compliance.
3. In the cases where the facility stores medicinal products and materials for commercial purposes, it shall submit an application form for inspection of GSP compliance and technical documents provided in the Appendix VI hereof to the receiving authority. The facility is only allowed to store medicinal products and materials for commercial purposes after the receiving authority inspects its compliance with GSP requirements.
4. The receiving authority specified in Clause 1 Article 6 of this Circular shall inspect and audit GSP compliance by the facility as prescribed in Article 15 of this Circular.
Article 15. Unexpected inspection or audit of GSP compliance and maintenance thereof by medicinal product and medicinal material storage facilities not required to obtain certificates of eligibility for pharmacy business
1. Unexpected inspection or audit of GSP compliance and maintenance thereof by medicinal product and medicinal material storage facilities not required to obtain certificates of eligibility for pharmacy business according to Articles 14 and 15 of this Circular shall be conducted as prescribed in Article 12 of this Circular.
2. Result of unexpected inspection of GSP compliance by a medicinal product and medicinal material storage facility not required to obtain certificates of eligibility for pharmacy business shall be processed as follows:
a) If the result of inspection of GSP compliance shows that the storage facility complies with GSP requirements at level 1 as prescribed in Point a Clause 3 Article 7 of this Circular, it is entitled to keep operating.
b) If the result of inspection of GSP compliance shows that the storage facility complies with GSP requirements at level 2 as prescribed in Point b Clause 3 Article 7 of this Circular, the inspecting authority shall request the storage facility in writing to rectify deficiencies and send a rectification report to the inspecting authority;
c) If the result of inspection of GSP compliance shows that the storage facility complies with GSP requirements at level 3 as prescribed in Point c Clause 3 Article 7 of this Circular, the inspecting authority shall decide to suspend the storage operations that fail to comply with GSP requirements until the result of deficiency rectification is satisfactory.
d) If it is concluded that a sample of medicinal product or medicinal material collected by the inspectorate during the inspection violates quality regulations due to the storage facility’s failure to comply with GSP requirements, the receiving authority shall handle it in accordance with applicable regulations on management of quality of medicinal products and materials. The head of the storage facility shall be responsible to law for such violation.
Article 16. Roadmap for GSP compliance by pharmacy establishments not required to obtain certificates of eligibility for pharmacy business
1. As of July 01, 2019, facilities that store and supply vaccines (storage facilities for storage of vaccines under national Expanded Program on Immunization at central, regional, provincial or district level, vaccination clinics, health facilities involved in vaccination) shall apply and comply with corresponding GSP requirements mentioned in this Circular.
2. As of January 01, 2021, major storage facilities for storage of medicinal products and medicinal materials under national health program and of the military, health facilities (other than health facilities involved in vaccination activities according to Clause 1 of this Article) and health facilities applying traditional medicine shall comply with corresponding GSP requirements mentioned in this Circular.
INSPECTORATE CONDUCTING INSPECTIONS OF GSP COMPLIANCE
Article 17. Members and standards to be satisfied by members of an inspectorate
1. An inspectorate includes:
a) the chief, and 01 member of the receiving authority. 01 member of the Traditional Medicine Administration of Vietnam, regarding the storage facility specified in Point c Clause 1 Article 6 of this Circular;
b) 01 member: the representative of the Department of Health of the province where the warehouse is located;
c) Members of relevant authorities where necessary.
2. A member of the inspectorate must satisfy the following standards:
a) He/she must obtain at least a bachelor’s degree in medicine, pharmacy, chemistry or biology;
b) He/she has been trained in GSP and inspection of GSP compliance, and has a thorough grasp of GSP requirements;
c) He/she must be honest, objective strictly comply with regulations during the inspection and must not create any conflict of interest with the inspected storage facility as prescribed in Clause 3 of this Article;
d) The chief must obtain at least a bachelor’s degree in pharmacy and have at least 02 (two) years’ experience in pharmacy management.
3. Rules for assessing the conflict of interest: A member of the inspectorate shall be deemed to involve a conflict of interest with the inspected storage facility in one of the following cases:
a) He/she worked for the inspected storage facility in the last 05 years;
b) He/she participated in providing consulting services for the inspected storage facility in the last 05 years;
c) He/she is receiving financial benefits associated with the inspected storage facility;
d) His/her spouse, child, parent, sibling or parent-in-law is working for the inspected storage facility.
Article 18. Rights and responsibilities of an inspectorate
1. The inspectorate has the responsibility to:
a) inspect all operations of a storage facility according to corresponding GSP prescribed in Article 3 of this Circular, updated versions of GSP requirements and relevant legislative documents and regulations; clearly record inspection contents and deficiencies found, prepare GSP inspection records and reports;
b) report inspection results or provide explanation for the GSP inspection report if the storage facility has any disagreements with the report;
c) maintain confidentiality of all information about storage of medicinal products and materials by storage facilities unless otherwise agreed upon by the storage facility or requested by the competent authority.
2. The inspectorate has the right to:
a) inspect all areas and warehouses of the storage facility and request inspection of other areas related to the storage of medicinal products and materials;
b) request the storage facility to provide documents concerning its trading in, management of quality and storage of medicinal products and materials;
c) collect documentary evidences (by copying documents, taking pictures or recording videos) of deficiencies found during the inspection;
d) take samples of medicinal products and materials to test their quality as regulated by law;
dd) make inspection records and request the storage facility to suspend the storage operations at one, some or all of warehouses. During the inspection, if the inspectorate finds that the storage facility commits a violation which seriously affects quality of one or multiple medicinal products and materials, it is required to notify the competent person thereof.
IMPLEMENTATION CLAUSE
1. This Circular comes into force from January 10, 2019.
2. The following documents and regulations are null and void from the effective date of this Circular:
a) Decision No. 2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health;
b) Regulations on GSP specified in the Decision No. 27/2007/QD-BYT dated April 19, 2007 of the Minister of Health;
c) Regulations on GSP specified in the Decision No. 45/2011/TT-BYT dated December 21, 2011, Decision No. 2701/2001/QD-BYT dated June 29, 2001, Circular No. 06/2004/TT-BYT dated May 28, 2004, Decision No. 3886/2004/QD-BYT dated November 03, 2004, Circular No. 13/2009/TT-BYT dated September 01, 2009, Circular No. 22/2009/TT-BYT dated November 24, 2009 and Circular No. 47/2010/TT-BYT dated December 29, 2010 of the Minister of Health;
d) Regulations on GSP for herbal medicinal materials specified in the Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health;
dd) Regulation: “If the drug retailer fails to submit an application for periodic inspection as prescribed, the Department of Health shall revoke its certificate of eligibility for pharmacy business as prescribed in Clause 2 Article 40 of the Law on Pharmacy” specified in Clause 5 Article 9 of the Circular No. 02/2018/TT-BYT dated January 22, 2018 of the Minister of Health;
e) Regulation: “If the distributor fails to submit an application for periodic inspection as prescribed, the Department of Health shall revoke its certificate of eligibility for pharmacy business as prescribed in Clause 2 Article 40 of the Law on Pharmacy” specified in Clause 5 Article 9 of the Circular No. 03/2018/TT-BYT dated February 09, 2018 of the Minister of Health.
In the cases where any of the legislative documents and regulations referred to in this Circular is amended or replaced, the newest one shall apply.
Article 21. Transitional clauses
1. Any pharmacy establishment that has been issued with the certificate for eligibility for pharmacy business that allows storage of medicinal products and materials or certificate of GSP compliance before the effective date of this Circular is entitled to store medicinal products and materials until the expiry date of such certificate.
If the certificate of eligibility for pharmacy business expires, the storage facility shall apply for such certificate as prescribed by law.
If the certificate of GSP compliance expires before the expiry date of the certificate of eligibility for pharmacy business, the storage facility shall apply for inspection of maintenance of GSP compliance according to Chapter IV of this Circular in order to keep operating until the expiry date written on its certificate of eligibility for pharmacy business.
2. If a pharmacy establishment has been issued with the certificate for eligibility for pharmacy business that allows storage of medicinal products and materials and does not specify an expiry date, it shall apply for inspection of GSP compliance and follow relevant procedures as prescribed by law in case of expiry of the certificate of GSP compliance.”
3. Regarding applications for certificate of eligibility for pharmacy business or applications for periodic inspection of GSP compliance submitted to the receiving authority before the effective date of this Circular, the receiving authority shall inspect the storage facility according to GSP promulgated together with the Decision No. 2701/2001/QD-BYT dated June 29, 2001 of the Minister of Health.
4. If a pharmacy establishment that has been issued with the certificate for eligibility for pharmacy business has a GSP-compliant herbal medicinal material warehouse that has been inspected and published by the Traditional Medicine Administration of Vietnam on its website as prescribed in the Circular No. 03/2016/TT-BYT dated January 21, 2016 of the Minister of Health, it may keep storing imported and exported herbal medicinal materials within 03 (three) years from the publishing date.
Article 22. Responsibility for implementation
1. The Drug Administration of Vietnam shall:
a) take charge and cooperate with relevant units in organizing the dissemination of this Circular. Take charge of compiling a list of GSP criteria relevant to each type of storage facility according to the principle of transparency, clarity and accuracy and request the Ministry of Health to promulgate it to form a basis for application of GSP to storage facilities and inspection by pharmacy authorities;
b) within its jurisdiction, instruct Departments of Health, health authorities and medicinal product and medicinal material storage facilities to implement this Circular;
c) consolidate and publish the list of storage facilities that have been granted the certificate of eligibility for pharmacy business and/or Certificate of GSP compliance, status of such certificates, status of GSP compliance and other information on its website according to Clause 4 Article 8 of this Circular within its jurisdiction;
d) publish updated GSP documents on its website and the web portal of the Ministry of Health;
dd) receive notifications of GSP compliance by medicinal product and medicinal material storage facilities not required to obtain certificates of eligibility for pharmacy business according to Clause 3 Article 4 of this Circular except for storage facilities for storage of vaccines under Expanded Program on Immunization in provinces and districts;
e) take charge or cooperate with the Ministry Inspectorate in inspecting the compliance with regulations of this Circular and take actions against violations within its power.
2. The Traditional Medicine Administration of Vietnam shall:
a) within its jurisdiction, instruct Departments of Health, health authorities and medicinal product and medicinal material storage facilities to implement this Circular;
b) consolidate and publish the list of storage facilities that have been granted the certificate of eligibility for pharmacy business or Certificate of GSP compliance, status of such certificates, status of GSP compliance and other information on its website according to Clause 4 Article 8 of this Circular within its jurisdiction;
c) carry out inspections and take actions against violations within its power.
3. Departments of Health shall:
a) cooperate with relevant units in organizing the dissemination of this Circular and instruct units within provinces to implement this Circular;
b) join the inspectorate conducting inspections of GSP compliance; within their power, supervise and takes actions against violations against regulations on GSP compliance by medicinal product and medicinal material storage facilities within provinces;
c) receive notifications of GSP compliance by local facilities involved in storage of medicinal products and not required to obtain certificates of eligibility for pharmacy business according to Clauses 4 and 5 Article 4 of this Circular and storage facilities for storage of vaccines under Expanded Program on Immunization in provinces and districts.
4. Medicinal product and medicinal material storage facilities shall:
a) organize the implementation of regulations of law on pharmacy and standards promulgated together with this Circular;
b) ensure their compliance with GSP requirements during their operation;
c) store medicinal products and materials within the inspected and licensed scope according to regulations of law and eligibility requirements for storage by storage facilities;
d) import but not distribute medicinal products and medicinal materials according to Point c Clause 10 Article 91 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 and relevant regulations of law.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.
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PP. THE MINISTER |
APPENDIX I
GOOD STORAGE PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
1. Glossary
“batch of medicinal products and medicinal materials” (hereinafter referred to as “the batch”) means a defined quantity of medicinal products and materials processed in a single process or series of processes so that it is expected to be homogeneous.
“batch number” means a distinctive combination of numbers and/or letters which uniquely identifies a batch.
“consignment” means quantity of medicinal products and materials supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include medicinal products and materials belonging to more than one batch.
“retest date” means the date when a material should be re-examined to ensure that it is still suitable for use.
“packaging material” means any material, including printed material, employed in the packaging of a medicinal product or medicinal material, but excluding any outer packaging used for transportation or shipment. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
“storage” means the storing of medicinal products and materials up to their point of use.
“quarantine” means the status of medicinal products and materials isolated physically or by other effective means while a decision is awaited on their release, rejection or reprocessing.
“sampling” means operations designed to obtain a representative portion of a medicinal product or medicinal material, based on an appropriate statistical procedure, for a defined purpose, e.g. acceptance of consignments or batch release.
“contamination” means the undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a medicinal material, or intermediate or finished product during production, sampling, packaging or repackaging, storage or transport.
“supplier” means a person providing medicinal products and materials on request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where possible, suppliers should be authorized by a competent authority.
“quality system” means an appropriate infrastructure, encompassing the organizational structure, procedures, processes and resources, and systematic actions necessary to ensure adequate confidence that a product (or services) will satisfy given requirements for quality.
“standard operating procedure” (SOP) means an authorized, written procedure giving instructions for performing operations not necessarily specific to a given product but of a more general nature (e.g. equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection).
2. Organization and management
2.1. There should be an adequate organizational structure for each entity, defined with the aid of an organizational chart that clearly identifies responsibilities, authorities and interrelationships of all personnel.
2.2. There should be documented and approved job descriptions that clearly define duties and responsibilities of each employee. The responsibilities placed on employees should not be so extensive to avoid work overload and relevant to their qualifications. Duties and responsibilities should be clearly understood by the individuals concerned.
2.3. Responsibilities of a chief pharmacist:
a) Assume responsibility for storage activities of a facility, including the compliance with regulations on product quality;
b) Grant or authorize another person holding equivalent qualifications to grant approval for receipt or release of products.
2.4. A designated competent person who has defined authority and responsibility and is provided with necessary resources shall be appointed to ensure that a quality system is implemented and maintained and correct deviations from the established quality system.
2.5. Managerial and technical personnel must have the authority and resources needed to carry out their duties and to set up and maintain a quality system.
3. Personnel
Qualifications and experience
3.1. At each storage facility, there should be an adequate number of qualified personnel to carry out operations involving receipt, release, storage, loading, unloading, cleaning and maintenance and other operations to ensure quality of medicinal products and materials. Where:
a) Regarding medicinal products and materials not required to be under special control, the warehouse-keeper for a storage facility must:
- have necessary qualifications and knowledge of pharmacy and storage practices (storage methods, document management, receipt and release monitoring, quality of medicinal products and materials, etc.).
- obtain at least an intermediate professional education diploma in pharmacy in case of the facility storing chemical medicinal products, vaccines and medical biologicals.
b) Regarding special-controlled medicinal products and materials, personnel shall comply with regulations specified in Articles 44 and 45 of the Decree No. 54/2017/ND-CP, Clause 19 Article 4 and Clauses 21 and 22 Article 5 of the Decree No. 155/2018/ND-CP, Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health and other relevant regulations.
Training
3.2. All personnel should receive proper training in relation to good storage practice, regulations, procedures and safety. Personnel should receive initial and continuing training relevant to their tasks on an annual basis, and be assessed as applicable to evaluate the effectiveness of the actions taken.
3.3. All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation.
3.4. Personnel involved in the receipt, storage, packaging and repackaging of special-controlled medicinal products and materials; highly active medicinal products and materials (sexual hormone, cytotoxics, etc.), highly sensitive medicinal products and materials (beta-lactam antibiotics, etc.) and products presenting special risks of abuse, fire or explosion (combustible or flammable liquids, solids and pressurized gases) should be given specific training.
Other requirements
3.5. Personnel should be entitled to periodic health check-ups as prescribed by law. Personnel with respiratory diseases or open wounds should not directly work in storage areas where medicinal products and materials with open packaging materials are handled.
3.6. Personnel working in storage areas shall wear protective garments suitable for the activities that they perform. Personnel dealing with hazardous medicinal products and materials shall be provided with protective garments as necessary.
4. Quality system
4.1. There shall be a documented quality policy describing the overall intentions and requirements of the storage facility regarding quality. This policy shall be authorized by management, communicated and understood by all personnel.
4.2. The quality system should include an appropriate organizational structure, procedure, processes and resources and systematic actions necessary to ensure adequate confidence that a product or service and its documentation will satisfy given requirements for quality.
4.3. The quality system should include provisions to ensure that the storage facility, manufacturer, importer, medicine/pharmacy authorities, as well as other relevant competent authorities, would be informed immediately in a case of confirmed or suspected counterfeiting of a medicinal product or medicinal material. Such products should be stored in a secure, segregated area and clearly identified to prevent further distribution or sale.
4.4. Where electronic commerce (e-commerce) is used in one, some or all of operations involving receipt, storage, release, inspection and monitoring of quality, defined procedures and adequate systems should be in place to ensure traceability and confidence in the quality of the medicinal products concerned.
4.5. Storage facilities should adopt regulations and assess suppliers and distributors to ensure that appropriate medicinal products and materials are sourced only from approved suppliers and distributed by approved entities.
4.6. Storage facilities should from time to time conduct risk assessments to assess potential risks to the quality and integrity of medicinal products and materials. The quality system should be developed and implemented to address any potential risks identified. The quality system should be reviewed and revised periodically to address new risks identified during a risk assessment.
Traceability of medicinal products and materials
4.7. There should be regulations in place to ensure document traceability of products received, stored, quarantined, released and returned, to facilitate product recall or other necessary operations.
4.8. There should be records in place to specify information about all facilities involved in the supply, distribution, storage, use and transport of medicinal products and materials, stating at least names and address of such facilities.
4.9. Regulations and measures shall be in place to ensure that each batch has documentation that can be used to permit traceability of the products or define the next route of products.
5. Premises and facilities
5.1. Warehouses should be built at a dry, airy and safe place and have a drainage system to ensure that medicinal products and materials are protected from underground water, heavy rain, and flood.
Warehouses must have a fixed address and have systems of public or internal roads that are wide enough to facilitate the transport, receipt, release and fire protection.
5.2. Warehouses should be designed, constructed, equipped, repaired and maintained in such a systematic manner as to protect medicinal products and materials from all potentially harmful influences such as undue variations of temperature and humidity; dust and odor; entry of animals, vermin and insects, and to avoid affecting quality of medicinal products and materials.
Ceilings, walls and roofs of warehouses must be sturdy, airy, and able to withstand weather impacts such as sunlight, rain, storm and flood.
The ground of a warehouse must be adequately elevated, flat, smooth and hard, and able to withstand the impact of underground water to ensure smooth operations carried out by employees working therein and easy movement of vehicles. There should be no cracks which are places for dust and insects.
5.3. A warehouse must be wide enough to create space for the following operations:
- Receipt and inspection of receipt of medicinal products and materials, cleaning of containers;
- Quarantine (after being received, medicinal products and materials are isolated physically or by other effective means while a decision is awaited on inspection and control of their quality)
- Inspection and control of quality of medicinal products and materials;
- Sample collection, handling of sampling tools;
- Storage of medicinal products and materials;
- Storage of medicinal products and materials requiring special storage conditions;
- Storage of medicinal products and materials that must be under special control or separately stored;
- Quarantine of products awaiting handling (in case products are returned, recalled or suspected to be counterfeit or any doubt arises over their quality, etc.);
- Quarantine of rejected medicinal products and materials prior to their disposal;
- Storage of released medicinal products and materials awaiting transport;
- Shipment containers and container labeling;
- Release;
- Storage of packaging materials;
- Storage of equipment and tools serving loading, unloading and movement;
- Attachment of secondary labels by importers of medicinal products;
- Change of clothes, storage of protective garments and warehouse office.
5.4. Areas of the warehouse should have signs clearly indicating capacity of each area, have appropriate size and volume and provide enough space to allow categorization and arrangement of medicinal products and materials by their type and separation of each type and batch to ensure air circulation.
Where necessary, areas of a warehouse may be suitably spaced for storage purpose but storage conditions should be maintained.
5.5. Storage areas shall be designed or adapted to ensure appropriate and good storage conditions and permit easy cleaning.
5.6. Material sampling areas must be designed and have a system of equipment in accordance with regulations on material sampling areas specified in Circular of the Ministry of Health on GMP.
5.7. Warehouses of medicinal products presenting special risks of abuse, fire or explosion (e.g. combustible or flammable liquids, solids and pressurized gases) should be designed and constructed in accordance with regulations of law and isolated from other warehouses and residential houses. Such warehouses must be airy and provided with fireproof lights. Electric switches must be mounted outside warehouses.
5.7. Appropriate vehicles and equipment should be in place to ensure good storage conditions (e.g. ventilation fans, air-conditioning thermometers, trucks, forklifts, hygrometers, cold rooms, refrigerators, vaccine vial monitors, freeze tags, etc.). Equipment should be periodically inspected, serviced and maintained to ensure its stable and accurate operation. Measuring instruments should be periodically calibrated in accordance with regulations of law on verification and calibration of measuring instruments.
5.8. There should be devices (such as bells, lights and/or messages) that automatically detects and notices emergencies or deviations from storage conditions, especially in case of medicinal products requiring special storage conditions (temperature, humidity).
5.9. Adequate lighting should be provided to enable all operations to be carried out accurately and safely.
5.10. There should be enough pallets. Distance between pallets and between pallets and warehouse ground should be wide enough to permit cleaning, inspection and handling.
Pallets should be kept in a good state of cleanliness, periodically maintained and coded for easy identification in the warehouse.
5.11. There should be computers connected to the Internet and storage of medicinal products and materials should be managed using software. Mechanisms should exist to allow for transfer of information, including information about receipt, release and distribution of medicinal products and materials to a customer, and quality or regulatory information between a manufacturer and a customer, as well as the transfer of information to the relevant regulatory authority as required.
5.12. There should be enough firefighting equipment and firefighting precautions, such as automatic firefighting system, fire extinguishers, sand barrels and water and fire hose system.
5.13. Storage areas should be clean and free from accumulated waste and vermin. Extraneous odors, other indications of contamination, and intense light must be excluded.
5.14. Washing and toilet facilities should be well-ventilated and suitably spaced (isolated from medicinal product reception, storage and handling areas).
5.15. Regulations on entry into storage areas must be available and precautions must be taken to prevent unauthorized persons from entering storage areas.
5.16. Adequate lighting should be provided to enable all operations to be carried out accurately and safely. Medicinal products and materials should be protected from direct sunlight.
6. Storage of medicinal products and materials
6.1. Medicinal products and materials should be stored in conditions which assure that their quality is maintained. The “First Expires First Out” (FEFO) or “First In First Out” (FIFO) principle should be followed. In some cases, the aforementioned principle may not be followed but it is required to avoid distributing expired products.
6.2. Medicinal products and materials should be placed on pallets and panels and stored off the floor. Medicinal product and material packaging and containers may be stacked but measures should be in place to prevent any spillage or damage to lower packaging and containers.
6.3. Medicinal product containers should remain intact during storage. Do not use container of one product for another.
6.4. Receiving and dispatch bays should protect medicinal products and materials from the weather. Reception areas should be designed and equipped to allow containers of incoming medicinal products and materials to be cleaned, if necessary, before storage.
6.5. There should be measures against loss of special-controlled medicinal products and materials prescribed in the Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP and Circular No. 20/2017/TT-BYT and the following measures:
a) Storage areas of special-controlled medicinal products and materials should have signs clearly indicating each type of corresponding special-controlled medicinal products and materials.
b) Toxic medicinal products and toxic medicinal ingredients should be packaged in such a manner as to prevent their permeation and leakage during transportation.
6.6. Highly active medicinal products and materials (sexual hormone, etc.), highly sensitive medicinal products and materials (beta-lactam antibiotics, etc.), products presenting special risks of abuse, fire or explosion (e.g. combustible or flammable liquids and solids and pressurized gases) should be stored in a dedicated area(s) that is subject to appropriate additional safety and security measures in accordance with regulations of relevant legislative documents.
6.7. Odorous medicinal products and materials should be stored in tightly closed packaging materials in dedicated area(s) to prevent odor from other medicinal products and materials.
6.8. Light-sensitive medicinal products should be stored in closed packaging materials, enclosed spaces or dark rooms.
6.9. Volatile and humidity-sensitive medicinal products should be stored in cold storage warehouses or in tightly closed packaging materials. Highly hygroscopic substances shall be stored in a dry room, in hermetically sealed glass or plastic packaging, with the stopper coated in paraffin wax, if necessary.
6.10. Special attention should be paid to the arrangement and storage of some types of vaccines that are easily damaged by freezing (such as VGB, DPT, DT, Td, tetanus, DPT-VGB-Hib, Typhoid, cholera, etc.). Those vaccines should be placed at a distance from the refrigerator walls, floors and cold-air vents from the coil. They should be placed on top (in case of a top-opening refrigerator) or in the middle rack of the refrigerator (in case of a front-opening refrigerator). Safety of a storage area should be controlled using a freeze tag or temperature data logger and alarm device.
6.11. Physical quarantine measures should be available.
Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel.
. Any system replacing physical quarantine should provide equivalent security. For example, computerized systems can be used, provided that they are validated to demonstrate security of access to prevent mix-ups or loss of medicinal products and materials in quarantine.
6.12. Broken or damaged items should be withdrawn from usable stock and separated.
Broken or leaked products should be cleaned up as soon as possible to avoid contamination, cross-contamination and harm to other products or personnel. Documented procedures should be in place to deal with such issues.
Storage conditions
6.13. Storage conditions for medicinal products and materials should be in compliance with the labeling that has been approved or published as prescribed.
Unless otherwise specifically stated (e.g. continuous maintenance of cold storage) deviation may be tolerated only during short-term interruptions, for example, during local transportation.
6.14. Storage instructions:
a) Normal storage conditions:
It is required to store products in dry (humidity 75%), well-ventilated premises at temperatures of 15 - 30°C or, depending on climatic conditions, up to 30°C, but not exceeding 32°C and humidity must not exceed 80%. Extraneous odors, other indications of contamination, and intense light must be excluded.
If the label does not specify storage conditions, store at room temperature.
b) Special storage conditions: Medicinal products that must be stored under defined conditions require appropriate storage instructions.
c) Defined storage instructions:
On the label
“Do not store over 30°C” (from +2 °C to +30°C) “Do not store over 25°C” (from +2 °C to +25°C) “Do not store over 15°C” (from +2 °C to +15°C) “Do not store over 8°C” (from +2 °C to +8°C) “Do not store below 8°C” (from +8 °C to +25°C) “Cold storage” (from +2 °C to +8°C) “Cool storage” (from +8°C to +15°C)
“Dry”, “Protect from moisture” no more than 75% relative humidity in normal storage conditions; or to be provided to the patient in a moisture-resistant container.
“Protect from light” To be provided to the patient in a light-resistant container.
6.15. Storage conditions should be checked at defined intervals (at least twice per day). These intervals should be defined through continuous monitoring of storage conditions in warehouses and on a seasonal basis. The results of such checks should be recorded and retained. Records of storage condition monitoring data should be available for review.
6.16. It is recommended that equipment used for monitoring of storage conditions during storage and transportation be located in areas that are most likely to show fluctuations according to the results obtained from temperature mapping studies.
Each warehouse or storage area (in case the storage area provides a physical segregation and separate heating ventilation and air conditioning system) should provide at least 01 temperature monitor capable of automatically recording temperature data at suitable recording intervals (at least 30 minutes at a time). Automatic monitors should be placed at locations with the greatest temperature variability as determined by temperature mapping studies.
Regarding medicinal products and materials requiring special storage conditions (e.g. vaccines or biological), it is required to use equipment for continuously monitoring storage conditions (e.g. temperature) during their storage and transport. The use of monitoring equipment and data should be retained.
6.17. Temperature mapping of storage areas should be carried out in accordance with WHO guidance for the temperature mapping of storage areas. Temperature mapping should show uniformity of the temperature across the storage facility.
Labeling and containers
6.18. All medicinal products and materials should be stored in containers which do not adversely affect the quality of the products or materials concerned, and which offer adequate protection from external influences. In some circumstances, this could include bacterial contamination.
6.19. All containers should be clearly labeled in accordance with the Circular No. 01/2018/TT-BYT dated January 18, 2018. The containers not required to be labeled in accordance with Circular should be labeled with at least the name of the product, the batch number, the expiry date or retest date and the specific storage conditions.
6.20. Unauthorized abbreviations, names or codes should not be used. Internationally and/or nationally accepted abbreviations, names or codes should be used in the labeling of shipment containers.
Stock rotation and control
6.21. Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. In any case, the comparison shall be made as soon as each batch is used up.
6.22. All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue. Investigation records should be retained.
6.23. In case medicinal product and material containers are damaged or their labels are lost/torn/unclear or any doubt arises over their quality, they should not be issued. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.
6.24. Partly used containers of medicinal products and materials should be securely reclosed and resealed to prevent spoilage and/or contamination during subsequent storage.
Control of obsolete and outdated medicinal products and materials
6.25. All stocks should be checked regularly for obsolete and outdated medicinal products and materials. All due precautions should be observed to prevent the issue of outdated medicinal products and materials.
7. Receipt of incoming medicinal products and materials
7.1. On receipt, each incoming delivery should be checked against the relevant purchase order and each container physically verified, e.g. by the label description, batch number, type of medicinal product or material and quantity.
7.2. The consignment should be examined for uniformity of the containers and, if necessary, should be subdivided according to the supplier’s batch number.
7.3. Each container should be carefully inspected for possible contamination, tampering and damage, and any suspect containers or, if necessary, the entire delivery should be quarantined for further investigation. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.
All containers of medicinal products and materials that are damaged, have lost their seals or are suspected of contamination should not be received. If not destroyed immediately, they should be stored in quarantine areas and should not be sold or mixed up with other medicinal products and materials.
7.4. When required, samples should be taken only by appropriately trained and qualified personnel in accordance with the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Ministry of Health and in strict accordance with written sampling instructions. Containers from which samples have been taken should be labeled accordingly.
7.5. Following sampling, the goods should be subject to quarantine. Batch segregation should be maintained during quarantine and all subsequent storage.
7.6. Medicinal products and materials should remain in quarantine until an authorized release or rejection is obtained.
7.7. Measures should be taken to ensure that rejected medicinal products and materials cannot be used. They should be stored separately from other medicinal products and materials while awaiting destruction or return to the supplier.
8. Dispatch and transport
8.1. The dispatch and transport of medicinal products and materials should be carried out only after receipt of a delivery order. The receipt of the delivery order and the dispatch of the goods must be documented.
8.2. Only medicinal products and materials that meet quality standards and are unexpired should be dispatched and issued.
8.3. Medicinal products and materials in quarantine shall be allowed for dispatch by the competent person.
8.4. A storage facility that is entitled to import but is not entitled to distribute medicinal products and materials is only allowed to dispatch and deliver them to a wholesaler at the warehouse of the storage facility and is not allowed to transport them, except in the cases where they are transported from a customs warehouse to warehouses of the storage facility or between warehouses of the storage facility.
8.5. Where appropriate, it is recommended to use devices to monitor storage conditions such as temperature during transportation in accordance with the storage conditions written on approved or published labels. Monitoring records should be available for review.
8.6. Special care should be exercised when using dry ice in cold chains. In addition observing to safety precautions, it must be ensured that the material or product does not come into contact with dry ice, as this may adversely affect the product quality, e.g. by freezing.
8.7. Medicinal products and materials should be transported in such a way that their integrity is not impaired and that storage conditions are maintained.
8.8. The outside container should offer adequate protection from all external influences and should be indelibly and clearly labeled.
8.9. The delivery, receipt and transport of special-controlled medicinal products and materials shall comply with relevant regulations of law.
9. Procedures and documentation
General principles
9.1. Documents, and in particular instructions and procedures relating to any activity that could have an impact on the quality of medicinal products and materials shall be designed, completed, reviewed and distributed with care.
9.2. The title, nature, and purpose of each document should be clearly stated. The contents of documents should be clear and unambiguous. They must be laid out in an orderly fashion and be easy to check.
9.3. All documents should be completed, approved, signed and dated by an appropriate authorized person(s) and should not be changed without the necessary authorization.
9.4. Documents should be regularly reviewed and kept up-to-date. When a document has been revised, a system should exist to prevent inadvertent use of the superseded version.
9.5. All records must be readily retrievable, and be stored and retained using facilities that are safeguarded against unauthorized modification, damage, deterioration and/or loss of documentation.
9.6. Records should contain enough information to enable traceability of medicinal products and materials. Such records should facilitate the recall of a batch of a product, if necessary, as well as the investigation of counterfeit or potentially counterfeit medicinal products and materials.
9.7. Where the records are generated and kept in electronic form, backups should be maintained to prevent any accidental data loss.
9.8. Approved procedures and instructions should be available and legibly shown.
Procedures
9.9. There should be standard operating procedures (SOPs) for all activities in storage areas including the handling of expired stock. These should adequately describe the storage procedures, define the route of medicinal products and materials, maintenance of storage equipment, recording of storage conditions, safety of medicinal products in warehouses and during their transport, distribution and dispatch of products, preparation of documents including records on customers' orders, returned products, recall procedures, and information through the organization in the event of a product recall being required.
9.10. Procedures should be established and maintained for the preparation, review, approval, use of and control of changes to all documents relating to the storage process. Procedures must be in place for both internally generated documents and those from external sources (from providers providing maintenance and calibration services, etc.)
9.11. Written procedures for the dispatch of medicinal products should be established. Such procedures should take into account the nature of the product as well as any special precautions to be observed.
9.12. There should be procedures for carrying out temperature and humidity mapping of storage areas, cold compartments, refrigerators, trucks and other relevant equipment and vehicles.
9.13. Procedures should be in place for security services to prevent theft or tampering with goods at the storage facilities, destruction of unsaleable or unusable stocks and on retention of the records.
9.14. Procedures should be available for the handling of damaged and/or broken shipment containers to prevent possible contamination. Particular attention should be paid to those containing potentially toxic and hazardous products.
9.15. Written procedures should be in place for investigating and dealing with any failure to comply with storage requirements, e.g. temperature deviations.
9.16. It is required to establish and maintain procedures for the identification, collection, indexing, retrieval, storage, maintenance, disposal of and access to all applicable documentation.
9.17. Safety procedures relating to all relevant aspects including the safety of personnel and property, environmental protection and product integrity, should be in place.
9.18. A written sanitation program should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas.
9.19. There should also be a written program for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of the medicinal products and materials.
Documentation
9.20. Written instructions and records should be available which document all activities in the storage areas including the handling of expired stock.
9.21. Comprehensive records should be maintained showing all receipts and issues of materials and medicinal products according to a specified system, e.g. by batch number.
9.22. Records should be kept for each delivery. They should include the description of the goods, quality, quantity, supplier, supplier’s batch number, the date of receipt, assigned batch number and the expiry date.
9.23. Records for the dispatch of medicinal products should include at least the following information:
- date of dispatch;
- complete business name and address, type of entity responsible for the transportation, telephone number and names of contact persons;
- complete business name, address of the addressee;
- a description of the products including, e.g. name, dosage form and strength;
- applicable transport and storage conditions.
9.24. Permanent records, written or electronic, should exist for each stored product indicating recommended storage conditions, any precautions to be observed and retest dates (if any). Regulations concerning labels and containers should be respected at all times.
9.25. Separate records should be available for the storage of special-controlled medicinal products and materials prescribed in the Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP and Circular No. 20/2017/TT-BYT and other relevant legislative documents.
Retention and storage of records
9.26. Regulations on retention of records on each medicinal product and material should be complied with. Where requirements are not in place, the records should be retained for at least 01 (one) year after the expiry date of the batch of medicinal products and materials.
10. Returned goods
10.1. Returned goods, including recalled goods, should be handled in accordance with approved procedures and records should be maintained.
10.2. All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re-evaluation.
10.3. Any stock reissued should be so identified and recorded in stock records.
10.4. Records of all returned, rejected and/or destroyed medicinal products and materials should be kept for a predetermined period.
10.5. All returned medicinal products and materials which are evaluated by the quality control department that they fail to meet quality and safety standards should be handled in accordance with regulations of law.
11. Recalls
11.1. There should be a system, which includes a written procedure, to recall from the market, promptly and effectively, medicinal products and materials known or suspected to be defective, with a designated person(s) responsible for recalls. The system should comply with regulations and law. This procedure should be checked regularly and updated as necessary.
11.2. All recalled medicinal products and materials should be stored in a secure, segregated area pending appropriate action. Where segregation is not possible, such products must be securely packaged, clearly labeled, and be accompanied by appropriate documentation.
11.3. The particular storage conditions applicable to a medicinal product which is subject to recall should be maintained during storage and transit until such time as a decision has been made regarding the fate of the product in question.
11.4. All records should be readily available to the designated person(s) responsible for recalls.
These records should contain sufficient information on medicinal products and materials supplied to customers (including exported medicinal products and materials).
12. Self-inspection
12.1. The quality system should include self-inspections. These should be conducted to monitor implementation and compliance with the principles of GSP and, if necessary, to trigger corrective and preventive measures (if any).
12.2. Self-inspections should be conducted in an independent and detailed way by a designated, competent person.
12.3. The results of all self-inspections should be recorded. Reports should contain all observations made during the inspection and, where applicable, proposals for corrective measures (if any). There should be an effective follow-up program. Management should evaluate the inspection report and the records of any corrective actions taken.
APPENDIX II
GOOD STORAGE PRACTICES FOR HERBAL MEDICINAL MATERIALS AND TRADITIONAL INGREDIENTS
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
1. Personnel
Qualifications and experience
1.1. At each storage facility, there should be an adequate number of qualified personnel to carry out operations involving release, receipt, storage, loading, unloading, cleaning and maintenance and other operations to ensure quality of herbal medicinal materials and traditional ingredients.
Where:
a) The chief pharmacist of an importer of herbal medicinal materials and traditional ingredients or provider of herbal medicinal material and traditional ingredient storage services must have qualifications and experience specified in Articles 17 and 22 of the Law on Pharmacy.
b) The warehouse-keeper must:
- have necessary qualifications and knowledge of pharmacy, herbal medicinal materials and traditional ingredients and storage practices (storage methods, document management, receipt and release monitoring, quality of herbal medicinal materials and traditional ingredients, etc.).
- obtain at least an intermediate professional education diploma in pharmacy.
1.2. There should be an adequate organizational structure for each entity, defined with the aid of an organizational chart that clearly identifies responsibilities, authorities and interrelationships of all personnel.
There should be approved job descriptions that clearly define duties and responsibilities of each employee. The responsibilities placed on employees should not be so extensive to avoid work overload and relevant to their qualifications. Duties and responsibilities should be clearly understood by the individuals concerned.
Training
1.3. All personnel should receive proper training in relation to good storage practice, regulations, procedures and safety.
1.4. All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation.
Other requirements
1.5. Personnel should be entitled to periodic health check-ups as prescribed by law.
1.6. Personnel working in storage areas shall wear garments suitable for the activities that they perform.
2. Location of the warehouse:
2.1. The warehouse should be built at a dry, airy and safe place and have a drainage system to ensure that herbal medicinal materials and traditional ingredients are protected from underground water, heavy rain, and flood.
2.2. The warehouse should have a fixed address and its location is convenient for delivery of herbal medicinal materials and traditional ingredients.
3. Design and construction of the warehouse:
3.1. The warehouse should have a sufficient area which is suitable for the scope of business in order to allow the orderly storage of the various categories of products. A warehouse must be wide enough to create space for the following operations:
- Receipt, inspection of receipt and cleaning of containers;
- Inspection and control of quality of herbal medicinal materials and traditional ingredients;
- Sample collection, handling of sampling tools;
- Storage of herbal medicinal materials and traditional ingredients;
- Storage of toxic herbal medicinal materials and traditional ingredients;
- Quarantine of products awaiting handling (in case products are returned, recalled or suspected to be counterfeit or any doubt arises over their quality, etc.)
- Quarantine of rejected goods prior to their disposal;
- Shipment containers and container labeling;
- Release;
- Storage of packaging materials;
- Storage of equipment and tools serving loading, unloading and movement;
- Change of clothes, storage of protective garments and warehouse office.
3.2. The minimum area and minimum volume of an importer of herbal medicinal materials and traditional ingredients or provider of herbal medicinal material and traditional ingredient storage services should be at least 500 m2 and 1.500 m3 respectively.
3.3. The reception area, receipt inspection area, area for storage of herbal medicinal materials and area for storage of traditional ingredients should be isolated from other areas to avoid cross-contamination and dust.
Roads in areas should allow movement in only one direction in accordance with the diagram of location and design of the warehouse.
3.4. Sampling areas should be suitably designed and provided with equipment to ensure sampling.
3.5. Areas of the warehouse should have signs clearly indicating capacity of each area, have appropriate size and volume and provide enough space to allow categorization and arrangement of herbal medicinal materials and traditional ingredients.
3.6. Storage areas should be able to prevent insects, rodents, and other animals; prevent the development of molds, fungi, termites, and cross-contamination.
3.7. The ceiling, walls, and roof of the warehouse must be sturdy, airy, and able to withstand weather impacts such as sunlight, rain, storm and flood.
3.8. The ground of a warehouse must be adequately elevated, flat, smooth and hard, and able to withstand the impact of underground water to ensure smooth operations carried out by employees working therein and easy movement of vehicles. There should be no cracks which are places for dust and insects
4. Equipment
4.1. Appropriate vehicles and equipment should be in place to ensure good storage conditions (e.g. ventilation fans, heating, ventilation and air conditioning system, trucks, forklifts, thermometers, hygrometers, etc.). Dehumidifiers should be in place to ensure storage conditions during rainy season or wet season.
Equipment used for monitoring storage conditions such as thermometers and hygrometers should be periodically checked and calibrated. The results of such checks and calibration should be recorded and retained.
4.2. Adequate lighting should be provided to enable all operations to be carried out accurately and safely.
4.3. There should be enough pallets.
Distance between pallets and between pallets and warehouse ground should be wide enough to permit cleaning and avoid waste and dust (at least 15 cm). Herbal medicinal materials should not be placed directly on the ground of the warehouse.
Distance between pallets and between pallets and warehouse ground should be wide enough to facilitate the movement and operation of vehicles involved in the loading, unloading, transport and cleaning, and to facilitate inspection and comparison.
4.4. There should be enough firefighting equipment and firefighting instructions.
4.5. Regulations on entry into storage areas must be available and precautions must be taken to prevent unauthorized persons from entering storage areas.
5. Sanitation
5.1. Storage areas should be clean and free from accumulated waste and vermin. A written sanitation program should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas.
5.2. All warehouse-keepers and personnel working in storage areas should be entitled to periodic health check-ups. Washing and toilet facilities should be well-ventilated and suitably spaced (isolated from reception, storage and handling areas).
5.3. Personnel working in storage areas shall wear suitable protective garments. There should be changing rooms and personal lockers.
6. Storage procedures
6.1. General requirements:
a) Herbal medicinal materials and traditional ingredients should be appropriately rotated. The “First Expires First Out” (FEFO) or “First In First Out” (FIFO) principle should be followed.
b) Rejected herbal medicinal materials and traditional ingredients should be identified and controlled under a quarantine system designed to prevent their use until a final decision is taken on their fate.
c) There should be regulations and program for periodic or unexpected inspection or re-evaluation, depending on the nature and conditions for storage of a product, in order to determine its compliance with standards and conformity for its use, e.g. after a long period of storage or exposure to temperature (hot) or humidity.
d) A system of documents and operating procedures should be in place to facilitate the storage, inspection and control of receipt, release and quality of herbal medicinal materials and traditional ingredients.
dd) Herbal medicinal materials and traditional ingredients should be stored in dry, well-ventilated premises at temperatures of 15–25°C or, depending on climatic conditions, up to 30°C. In dry premises, the relative humidity should not exceed 70%.
6.2. Labeling and containers:
a) Herbal products and traditional ingredients should be stored in suitable containers which offer adequate protection from external influences.
b) All containers should be clearly labeled and legible, and contain sufficient information in accordance with regulations of law on labels of herbal medicinal materials and traditional ingredients. Unauthorized abbreviations, names or codes should not be used.
c) Permanent records should exist for each container, label or stored product indicating recommended storage conditions, any precautions to be observed and expiry date (if any).
d) There should be a separate area for storage of labels and printed containers. Regulations on receipt and issue of these labels and containers should be available.
dd) Pharmacopoeial requirements and current national regulations concerning labels and containers should be respected at all times.
6.3. Receipt of herbal medicinal materials and traditional ingredients shall be carried out at reception areas and isolated from storage areas. Reception areas should protect herbal medicinal materials and traditional ingredients from the weather while awaiting handling.
6.4. Inspection of receipt of herbal medicinal materials and traditional ingredients:
a) On receipt, herbal medicinal materials and traditional ingredients should be checked against relevant documents about type, quantity and other information on the label, such as name of the product, manufacturer, supplier, batch number, expiry date, etc.
b) The consignment should be examined for uniformity of the containers and, if necessary, should be subdivided according to the supplier’s batch number;
c) All containers of herbal medicinal materials and traditional ingredients that are damaged, have lost their seals or are suspected of contamination should not be received. If not destroyed immediately, they should be stored in quarantine areas and should not be sold or mixed up with other herbal medicinal materials and traditional ingredients;
d) Herbal medicinal materials and traditional ingredients requiring cold storage conditions should be quickly checked, categorized and stored in accordance with the instructions written on the label and regulations of law.
6.5. Storage of herbal medicinal materials and traditional ingredients:
a) Herbal products and traditional ingredients should be stored in dry and airy warehouses. Containers should be appropriately arranged to ensure air circulation. Containers may be made of glass, plastic, paper, etc. Herbal products and traditional ingredients that contain essential oil should be stored in closed containers.
b) Toxic herbal products and traditional ingredients should be stored in accordance with relevant regulations.
c) Herbal medicinal material and tradition medicinal product containers should remain intact during storage. Do not use container of one product for another.
d) Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. In any case, the comparison shall be made as soon as each batch is used up.
dd) All discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue.
e) Batch numbers and expiry dates should be regularly checked to ensure that FIFO or FEFO principle is followed and to identify the products that are closest to their expiry date or expired.
g) Quality of inventory should be periodically inspected to identify damages during the storage due to temperature, humidity or other factors that are likely to affect quality of herbal medicinal materials and traditional ingredients.
h) The herbal medicinal materials and traditional ingredients that fail to meet quality standards or expired should be stored in separate areas, labeled and marked as products awaiting handling. Measures should be in place to prevent the issue or use of the herbal medicinal materials and traditional ingredients that fail to meet quality standards or are expired.
6.6. Issue - Stock rotation (Regulations on transport are not applicable to facilities that are entitled to import but are not entitled to distribute medicinal products).
a) Only medicinal products and materials that meet quality standards or are unexpired should be issued. In case containers are no longer intact or any doubt arises over the quality, they should not be issued or distributed.
b) The issue and loading of medicinal products and materials onto vehicles should be carried out only after receipt of a written delivery order. Written procedures for the dispatch of medicinal products and materials should be established. Such procedures should take into account the nature of the product as well as any special precautions to be observed.
c) The “first expired/first out” (FEFO) principle should be followed upon issue.
d) Regarding products requiring special storage conditions, such conditions should be ensured during transportation.
e) Partly used containers of herbal medicinal materials should be securely reclosed and resealed to prevent spoilage and/or contamination during subsequent storage.
g) Herbal medicinal material and traditional ingredient containers that are damaged or whose seals are broken or whose labels are torn/unclear should not be sold or issued and immediately reported to the quality control department.
h) Records for dispatch should state at least the date of dispatch, the customer’s name and address; the product name and quantity.
7. Returned goods
7.1. All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re-evaluation.
7.2. All returned herbal medicinal materials and traditional ingredients which are evaluated by the quality control department that they fail to meet quality and safety standards should be handled in accordance with regulations of law.
8. Documentation
8.1. Operating procedures should be available and legibly shown. They should be approved by a competent person. These procedures should accurately describe the storage procedures.
8.2. Appropriate documentation should be in place to facilitate the recording and monitoring of release and receipt of herbal medicinal materials. Computerized documentation shall comply with regulations of law. Regulations and precautions should be in place to avoid unauthorized access, use or correction of retained data.
8.3. Records should be kept for each receipt and comply with regulations of law on document retention. All records should be kept for at least the shelf-life of the stored herbal medicinal material plus one year.
APPENDIX III
GOOD STORAGE PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS APPLICABLE TO NON-COMMERCIAL FACILITIES WHOSE OPERATION INVOLVES STORAGE OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
1. Personnel
Qualifications and experience
1.1. At each storage facility, there should be an adequate number of qualified personnel to carry out operations involving release, receipt, storage, loading, unloading, transport, cleaning and maintenance and other operations to ensure quality of medicinal products and materials. Where:
a) The chief pharmacist must have qualifications and experience specified in Articles 17 and 22 of the Law on Pharmacy.
b) Regarding medicinal products and materials not required to be under special control, the warehouse-keeper must:
- have necessary qualifications and knowledge of pharmacy and storage practices (storage methods, document management, receipt and release monitoring, quality of medicinal products and materials, etc.).
- obtain at least an intermediate professional education diploma in pharmacy in case of the facility storing chemical medicinal products, vaccines and medical biologicals.
c) Regarding special-controlled medicinal products and medicinal materials, personnel shall comply with regulations specified in Articles 44 and 45 of the Decree No. 54/2017/ND-CP, Clause 19 Article 4 and Clauses 21 and 22 Article 5 of the Decree No. 155/2018/ND-CP, Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health and other relevant regulations.
1.2. There should be an adequate organizational structure for each entity, defined with the aid of an organizational chart that clearly identifies responsibilities, authorities and interrelationships of all personnel.
There should be approved job descriptions that clearly define duties and responsibilities of each employee. The responsibilities placed on employees should not be so extensive to avoid work overload and relevant to their qualifications. Duties and responsibilities should be clearly understood by the individuals concerned.
Training
1.3. All personnel should receive proper training in relation to good storage practice, regulations, procedures and safety.
1.4. All members of staff should be trained in, and observe high levels of, personal hygiene and sanitation.
1.5. Personnel involved in the receipt, storage, packaging and repackaging of special-controlled medicinal products and materials; highly active medicinal products and medicinal materials (sexual hormone, cytotoxics, etc.), highly sensitive medicinal products and materials (beta-lactam antibiotics, etc.) and products presenting special risks of abuse, fire or explosion (combustible and flammable liquids and solids and compressed air) should be given specific training.
Other requirements
1.6. Personnel should be entitled to periodic health check-ups as prescribed by law. Personnel with respiratory diseases or open wounds should not directly work in storage areas where medicinal products and materials with open packaging materials are handled.
1.7. Personnel working in storage areas shall wear garments suitable for the activities that they perform. Personnel dealing with hazardous medicinal products and medicinal materials shall be provided with protective garments as necessary.
2. Premises and facilities
2.1. Warehouses should be built at a dry, airy and safe place and have a drainage system to ensure that medicinal products and materials are protected from underground water, heavy rain, and flood.
Warehouses must have a fixed address and have systems of public or internal roads that are wide enough to facilitate the transport, receipt, release and fire protection.
2.2. Warehouses should be designed, constructed, equipped, repaired and maintained in such a systematic manner as to protect medicinal products and materials from all potentially harmful influences such as undue variations of temperature and humidity; dust and odor; entry of animals, vermin and insects, and to avoid affecting quality of medicinal products and materials.
Ceilings, walls and roofs of warehouses must be sturdy, airy, and able to withstand weather impacts such as sunlight, rain, storm and flood.
The ground of a warehouse must be adequately elevated, flat, smooth and hard, and able to withstand the impact of underground water to ensure smooth operations carried out by employees working therein and easy movement of vehicles. There should be no cracks which are places for dust and insects.
2.3. A warehouse must be wide enough to create space for the following operations:
- Receipt and inspection of receipt of medicinal products and medicinal materials, cleaning of containers;
- Quarantine (after being received, medicinal products and materials are isolated physically or by other effective means while a decision is awaited on inspection and control of their quality);
- Inspection and control of quality of medicinal products and materials;
- Sample collection, handling of sampling tools;
- Storage of medicinal products and materials;
- Storage of medicinal products and materials requiring special storage conditions;
- Storage of medicinal products and materials that must be under special control or separately stored;
- Quarantine of products awaiting handling (in case products are returned, recalled or suspected to be counterfeit or any doubt arises over their quality, etc.);
- Quarantine of rejected medicinal products and materials prior to disposal;
- Storage of released medicinal products and materials awaiting transport;
- Shipment containers and container labeling;
- Release;
- Storage of packaging materials;
- Storage of equipment and tools serving loading, unloading and movement;
- Change of clothes, storage of protective garments and warehouse office;
2.4. Areas of the warehouse should have signs clearly indicating capacity of each area, have appropriate size and volume and provide enough space to allow categorization and arrangement of medicinal products and materials by their type and separation of each type and batch to ensure air circulation.
Where necessary, areas of a warehouse may be suitably spaced for storage purpose but storage conditions should be maintained.
2.5. Storage areas shall be designed or adapted to ensure appropriate and good storage conditions and permit easy cleaning.
2.6. Material sampling areas must be designed and have a system of equipment in accordance with regulations on material sampling areas specified in Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Ministry of Health.
2.7. Warehouses of medicinal products presenting special risks of abuse, fire or explosion (e.g. combustible or flammable liquids, solids and pressurized gases) should be designed and constructed in accordance with regulations of law and isolated from other warehouses and residential houses. Such warehouses must be airy and provided with fireproof lights. Electric switches must be mounted outside warehouses.
2.8. Appropriate vehicles and equipment should be in place to ensure good storage conditions (e.g. ventilation fans, air-conditioning thermometers, trucks, forklifts, hygrometers, cold rooms, refrigerators, vaccine vial monitors, freeze tags, etc.). Equipment should be periodically inspected, serviced and maintained to ensure its stable and accurate operation. Measuring instruments should be periodically calibrated in accordance with regulations of law on verification and calibration of measuring instruments.
2.9. There should be devices (such as bells, lights and/or messages) that automatically detect and notice emergencies or deviations from storage conditions, especially in case of medicinal products requiring special storage conditions (temperature, humidity).
2.10. Adequate lighting should be provided to enable all operations to be carried out accurately and safely.
2.11. There should be enough pallets. Distance between pallets and between pallets and warehouse ground should be wide enough to permit cleaning, inspection, loading and unloading.
Pallets should be kept in a good state of cleanliness, periodically maintained and coded for easy identification in the warehouse.
2.12. There should be computers connected to the Internet and storage of medicinal products and materials should be managed using software. Mechanisms should exist to allow for transfer of information, including information about receipt, release and distribution of medicinal products and medicinal materials to a customer, and quality or regulatory information between a manufacturer and a customer, as well as the transfer of information to the relevant regulatory authority as required.
2.13. There should be enough firefighting equipment and firefighting precautions, such as automatic firefighting system, fire extinguishers, sand barrels and water and fire hose system.
2.14. Storage areas should be clean and free from accumulated waste and vermin. Extraneous odors, other indications of contamination, and intense light must be excluded.
2.15. Washing and toilet facilities should be well-ventilated and suitably spaced (isolated from medicinal product reception, storage and handling areas).
2.16. Regulations on entry into storage areas must be available and precautions must be taken to prevent unauthorized persons from entering storage areas.
2.17. Adequate lighting should be provided to enable all operations to be carried out accurately and safely. Medicinal products and materials should be protected from direct sunlight.
3. Storage of medicinal products and materials
3.1. Medicinal products and materials should be stored in conditions which assure that their quality is maintained. The “First Expires First Out” (FEFO) or “First In First Out” (FIFO) principle should be followed. In some cases, the aforementioned principle may not be followed but it is required to avoid distributing expired products.
3.2. Medicinal products and materials should be placed on pallets and panels and stored off the floor. Medicinal product and material packaging and containers may be stacked but measures should be in place to prevent any spillage or damage to lower packaging and containers.
3.3. Medicinal product and material containers should remain intact during storage. Do not use container of one product for another.
3.4. Receiving and dispatch bays should protect medicinal products and materials from the weather. Reception areas should be designed and equipped to allow containers of incoming medicinal products and materials to be cleaned, if necessary, before storage.
3.5. There should be measures against loss of special-controlled medicinal products and materials prescribed in the Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP and Circular No. 20/2017/TT-BYT and the following measures:
a) Storage areas of special-controlled medicinal products and materials should have signs clearly indicating each type of corresponding special-controlled medicinal products and materials.
b) Toxic medicinal products and toxic medicinal ingredients should be packaged in such a manner as to prevent their permeation and leakage during transportation.
3.6. Highly active medicinal products and materials (sexual hormone, etc.), highly sensitive medicinal products and materials (beta-lactam antibiotics, etc.), products presenting special risks of abuse, fire or explosion (e.g. combustible or flammable liquids and solids and pressurized gases) should be stored in a dedicated area(s) that is subject to appropriate additional safety and security measures in accordance with regulations of relevant legislative documents.
3.7. Odorous medicinal products and materials should be stored in tightly closed packaging materials in dedicated area(s) to prevent odor from other medicinal products and materials.
3.8. Light-sensitive medicinal products and materials should be stored in closed packaging materials, enclosed spaces or dark rooms.
3.9. Volatile and humidity-sensitive medicinal products should be stored in cold storage warehouses or in tightly closed packaging materials. Highly hygroscopic substances shall be stored in a dry room, in hermetically sealed glass or plastic packaging, with the stopper coated in paraffin wax, if necessary.
3.10. Special attention should be paid to the arrangement and storage of some types of vaccines that are easily damaged by freezing (such as VGB, DPT, DT, Td, tetanus, DPT-VGB-Hib, Typhoid, cholera, etc.). Those vaccines should be placed at a distance from the refrigerator walls, floors and cold-air vents from the coil. They should be placed on top (in case of a top-opening refrigerator) or in the middle rack of the refrigerator (in case of a front-opening refrigerator). Safety of a storage area should be controlled using a freeze tag or temperature data logger and alarm device.
3.11. Measures should be in place to physically isolate quarantine areas in a warehouse. Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing physical quarantine should provide equivalent security. For example, computerized systems can be used, provided that they are validated to demonstrate security of access to prevent mix-ups or loss of medicinal products and medicinal materials in quarantine.
3.12. Broken or damaged items should be withdrawn from usable stock and separated.
Broken or leaked products should be cleaned up as soon as possible to avoid contamination, cross-contamination and harm to other products or personnel. Documented procedures should be in place to deal with such issues.
Storage conditions
3.13. Storage conditions for medicinal products and materials should be in compliance with the labeling that has been approved or published as prescribed.
Unless otherwise specifically stated (e.g. continuous maintenance of cold storage) deviation may be tolerated only during short-term interruptions, for example, during local transportation.
3.14. Storage instructions:
a) Normal storage conditions:
It is required to stored products in dry (humidity 75%), well-ventilated premises at temperatures of 15 - 30°C or, depending on climatic conditions, up to 30°C, but not exceeding 32°C and humidity must not exceed 80%. Extraneous odors, other indications of contamination, and intense light must be excluded.
If the label does not specify storage conditions, store at room temperature.
b) Special storage conditions: Medicinal products that must be stored under defined conditions require appropriate storage instructions.
c) Defined storage instructions:
|
On the label |
Means |
|
“Do not store over 30°C” |
from +2°C to +30°C |
|
“Do not store over 25°C” |
from +2°C to +25°C |
|
“Do not store over 15°C” |
from +2°C to +15°C |
|
“Do not store over 8°C” |
from +2°C to +8°C |
|
“Do not store below 8°C” |
from +8°C to +25°C |
|
“Cold storage” |
from +2°C to +8°C |
|
“Cool storage” |
from +8°C to +15°C |
|
“Dry”, “Protect from moisture” |
no more than 75% relative humidity in normal storage conditions; or to be provided to the patient in a moisture-resistant container. |
|
“Protect from light” |
to be provided to the patient in a light-resistant container |
3.15. Storage conditions should be checked at suitable predetermined intervals (at least twice per day). The results of such checks should be recorded and retained. Records of storage condition monitoring data should be available for review.
3.16. It is recommended that equipment used for monitoring of storage conditions during storage and transportation be located in areas that are most likely to show fluctuations, determined according to the results obtained from temperature mapping studies.
Each warehouse or storage area (in case the storage area provides a physical segregation and separate heating ventilation and air conditioning system) should provide at least 01 temperature monitor capable of automatically recording temperature data at suitable recording intervals (at least 30 minutes at a time). Automatic monitors should be placed at locations with the greatest temperature variability as determined by temperature mapping studies.
Regarding medicinal products and materials requiring special storage conditions (e.g. vaccines or biological), it is required to use equipment for continuously monitoring storage conditions (e.g. temperature) during their storage and transport. The use of monitoring equipment and data should be retained.
3.17. Temperature mapping of storage areas should be carried out in accordance with WHO guidance for the temperature mapping of storage areas. Temperature mapping should show uniformity of the temperature across the storage facility.
Labeling and containers
3.18. All medicinal products and materials should be stored in containers which do not adversely affect the quality of the products or materials concerned, and which offer adequate protection from external influences. In some circumstances, this could include bacterial contamination.
3.19. All packaging materials should be clearly labeled in accordance with the Circular No. 01/2018/TT-BYT dated January 18, 2018. The packaging materials not required to be labeled in accordance with Circular should be labeled with at least the name of the product, the batch number, the expiry date or retest date and the specific storage conditions.
3.20. Unauthorized abbreviations, names or codes should not be used. Internationally and/or nationally accepted abbreviations, names or codes should be used in the labeling of shipment containers.
Stock rotation and control
3.21. Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. In any case, the comparison shall be made as soon as each batch is used up.
3.22. All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue. Investigation records should be retained.
3.23. In case medicinal product and material containers are damaged or their labels are lost/torn/unclear or any doubt arises over their quality, they should not be issued. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.
3.24. Partly used containers of medicinal products and materials should be securely reclosed and resealed to prevent spoilage and/or contamination during subsequent storage.
Control of obsolete and outdated medicinal products and materials
3.25. All stocks should be checked regularly for obsolete and outdated medicinal products and materials. All due precautions should be observed to prevent the issue of outdated medicinal products and materials.
4. Receipt of incoming medicinal products and p materials
4.1. It is required to adopt regulations and assess the supplier to ensure that appropriate medicinal products and materials are sourced only from approved suppliers and distributed by approved entities.
4.2. On receipt, each incoming delivery should be checked against the relevant purchase order and each container physically verified, e.g. by the label description, batch number, type of medicinal product or material and quantity.
The consignment should be examined for uniformity of the containers and, if necessary, should be subdivided according to the supplier’s batch number.
4.3. Each container should be carefully inspected for possible contamination, tampering and damage, and any suspect containers or, if necessary, the entire delivery should be quarantined for further investigation. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.
All containers of medicinal products and materials that are damaged, have lost their seals or are suspected of contamination should not be received. If not destroyed immediately, they should be stored in quarantine areas and should not be sold or mixed up with other medicinal products and materials.
4.4. When required, samples should be taken only by appropriately trained and qualified personnel in accordance with the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Ministry of Health and in strict accordance with written sampling instructions. Containers from which samples have been taken should be labeled accordingly.
4.5. Following sampling, the goods should be subject to quarantine. Batch segregation should be maintained during quarantine and all subsequent storage.
4.6. Medicinal products and materials should remain in quarantine until an authorized release or rejection is obtained.
4.7. Measures should be taken to ensure that rejected medicinal products and materials cannot be used. They should be stored separately from other medicinal products and materials while awaiting destruction or return to the supplier.
5. Dispatch and transport
5.1. Regulations and measures should be in place to ensure that appropriate medicinal products and materials are sourced only from approved suppliers and distributed by approved entities.
5.2. The dispatch and transport of medicinal products and materials should be carried out only after receipt of a delivery order. The receipt of the delivery order and the dispatch of the goods must be documented.
5.3. Only medicinal products and materials that meet quality standards and are unexpired should be dispatched and issued. Medicinal products and materials in quarantine shall be allowed for dispatch by the competent person.
5.4. A storage facility that is entitled to import but is not entitled to distribute medicinal products and materials is only allowed to dispatch and deliver them to a wholesaler at the warehouse of the storage facility and is not allowed to transport them, except in the cases where they are transported from a customs warehouse to warehouses of the storage facility or between warehouses of the storage facility.
5.5. Where appropriate, it is recommended to use devices to monitor storage conditions such as temperature during transportation in accordance with the storage conditions written on approved or published labels. Monitoring records should be available for review.
5.6. Special care should be exercised when using dry ice in cold chains. In addition observing to safety precautions, it must be ensured that the material or product does not come into contact with dry ice, as this may adversely affect the product quality, e.g. by freezing.
5.7. Medicinal products and materials should be transported in such a way that their integrity is not impaired and that storage conditions are maintained.
5.8. The outside container should offer adequate protection from all external influences and should be indelibly and clearly labeled.
5.9. The delivery, receipt and transport of special-controlled medicinal products and materials shall comply with relevant regulations of law.
6. Procedures and documentation
General principles
6.1. Documents, and in particular instructions and procedures relating to any activity that could have an impact on the quality of medicinal products and materials shall be designed, completed, reviewed and distributed with care.
6.2. The title, nature, and purpose of each document should be clearly stated. The contents of documents should be clear and unambiguous. They must be laid out in an orderly fashion and be easy to check.
6.3. All documents should be completed, approved, signed and dated by an appropriate authorized person(s) and should not be changed without the necessary authorization.
6.4. Documents should be regularly reviewed and kept up-to-date. When a document has been revised, a system should exist to prevent inadvertent use of the superseded version.
6.5. All records must be readily retrievable, and be stored and retained using facilities that are safeguarded against unauthorized modification, damage, deterioration and/or loss of documentation.
6.6. Records should contain enough information to enable traceability of the medicinal products and materials. Such records should facilitate the recall of a batch of a product, if necessary, as well as the investigation of counterfeit or potentially counterfeit medicinal products and materials.
6.7. Where the records are generated and kept in electronic form, backups should be maintained to prevent any accidental data loss.
6.8. Approved procedures and instructions should be available and legibly shown.
Procedures
6.9. There should be standard operating procedures (SOPs) for all activities in storage areas including the handling of expired stock. These should adequately describe the storage procedures, define the route of medicinal products and materials, maintenance of storage equipment, recording of storage conditions, safety of medicinal products in warehouses and during their transport, distribution and dispatch of products, preparation of documents including records on customers' orders, returned products, recall procedures, and information through the organization in the event of a product recall being required.
6.10. Procedures should be established and maintained for the preparation, review, approval, use of and control of changes to all documents relating to the storage process. Procedures must be in place for both internally generated documents and those from external sources (from providers providing maintenance and calibration services, etc.)
6.11. Written procedures for the dispatch of medicinal products should be established. Such procedures should take into account the nature of the product as well as any special precautions to be observed.
6.12. There should be procedures for carrying out temperature and humidity mapping of storage areas, cold compartments, refrigerators, trucks and other relevant equipment and vehicles.
6.13. Procedures should be in place for security services to prevent theft or tampering with goods at the storage facilities, destruction of unsaleable or unusable stocks and on retention of the records.
6.14. Procedures should be available for the handling of damaged and/or broken shipment containers to prevent possible contamination. Particular attention should be paid to those containing potentially toxic and hazardous products.
6.15. Written procedures should be in place for investigating and dealing with any failure to comply with storage requirements, e.g. temperature deviations.
6.16. It is required to establish and maintain procedures for the identification, collection, indexing, retrieval, storage, maintenance, disposal of and access to all applicable documentation.
6.17. Safety procedures relating to all relevant aspects including the safety of personnel and property, environmental protection and product integrity, should be in place.
6.18. A written sanitation program should be available indicating the frequency of cleaning and the methods to be used to clean the premises and storage areas.
6.19. There should also be a written program for pest control. The pest-control agents used should be safe, and there should be no risk of contamination of the medicinal products and materials.
Documentation
6.20. Written instructions and records should be available which document all activities in the storage areas including the handling of expired stock.
6.21. Comprehensive records should be maintained showing all receipts and issues of materials and medicinal products according to a specified system, e.g. by batch number.
6.22. Records should be kept for each delivery. They should include the description of the goods, quality, quantity, supplier, supplier’s batch number, the date of receipt, assigned batch number and the expiry date.
6.23. Records for the dispatch of medicinal products should include at least the following information:
- date of dispatch;
- complete business name and address, type of entity responsible for the transportation, telephone number and names of contact persons;
- complete business name, address of the addressee;
- a description of the products including, e.g. name, dosage form and strength;
- applicable transport and storage conditions.
6.24. Permanent records, written or electronic, should exist for each stored product indicating recommended storage conditions, any precautions to be observed and retest dates (if any). Regulations concerning labels and containers should be respected at all times.
6.25. Separate records should be available for the storage of special-controlled medicinal products and materials prescribed in the Decree No. 54/2017/ND-CP, Decree No. 155/2018/ND-CP and Circular No. 20/2017/TT-BYT and other relevant legislative documents.
Retention and storage of records
6.26. Regulations on period of retention of records should be complied with. Otherwise such records should be retained for a period equal to the shelf-life of the batch of medicinal products and materials, where applicable, plus 01 (one) year.
7. Returned goods
7.1. Returned goods, including recalled goods, should be handled in accordance with approved procedures and records should be maintained.
7.2. All returned goods should be placed in quarantine and returned to saleable stock only after this has been approved by a nominated, responsible person following a satisfactory quality re-evaluation.
7.3. Any stock reissued should be so identified and recorded in stock records.
7.4. Records of all returned, rejected and/or destroyed medicinal products and materials should be kept for a predetermined period.
7.5. All returned medicinal products and materials which are evaluated by the quality control department that they fail to meet quality and safety standards should be handled in accordance with regulations of law.
8. Recalled products
8.1. There should be a system, which includes a written procedure, to recall from the market, promptly and effectively, medicinal products and materials known or suspected to be defective, with a designated person(s) responsible for recalls. The system should comply with regulations and law. This procedure should be checked regularly and updated as necessary.
8.2. All recalled medicinal products and materials should be stored in a secure, segregated area pending appropriate action. Where segregation is not possible, such products must be securely packaged, clearly labeled, and be accompanied by appropriate documentation.
8.3. The particular storage conditions applicable to a medicinal product which is subject to recall should be maintained during storage and transit until such time as a decision has been made regarding the fate of the product in question.
8.4. All records should be readily available to the designated person(s) responsible for recalls. These records should contain sufficient information on medicinal products supplied to customers (including exported products).
9. Self-inspection
9.1. The quality system should include self-inspections. These should be conducted to monitor implementation and compliance with the principles of GSP and, if necessary, to trigger corrective and preventive measures.
9.2. Self-inspections should be conducted in an independent and detailed way by a designated, competent person.
9.3. The results of all self-inspections should be recorded. Reports should contain all observations made during the inspection and, where applicable, proposals for corrective measures (if any). There should be an effective follow-up program. Management should evaluate the inspection report and the records of any corrective actions taken.
APPENDIX IV
GOOD STORAGE PRACTICES FOR MEDICINAL PRODUCTS APPLICABLE TO HEALTH FACILITIES
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
1. Personnel
Qualifications and experience
1.1. At each storage facility, there should be an adequate number of qualified personnel to carry out operations involving release, receipt, storage and issue of medicinal products and other operations to ensure quality of medicinal products. Where:
a) Regarding medicinal products not required to be under special control, the warehouse-keeper must:
- have necessary qualifications and knowledge of pharmacy and storage practices (storage methods, document management, receipt and release monitoring, etc.).
- obtain at least an intermediate professional education diploma in pharmacy.
b) Regarding special-controlled medicinal products, personnel shall comply with regulations specified in the Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health, Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 and other relevant regulations.
1.2. There should be approved job descriptions that clearly define duties and responsibilities of each employee. Duties and responsibilities should be clearly understood by the individuals concerned.
Training
1.3. All personnel should receive proper training in relation to good storage practice, regulations, procedures and safety.
1.4. Personnel involved in the receipt, storage, packaging and repackaging of special-controlled medicinal products; highly active medicinal products and materials (sexual hormone, cytotoxics, etc.), highly sensitive medicinal products (beta-lactam antibiotics, etc.) and products presenting special risks of abuse, fire or explosion (combustible and flammable liquids and solids and compressed air) should be given specific training.
Other requirements
1.6. Personnel should be entitled to periodic health check-ups as prescribed by law. Personnel with respiratory diseases or open wounds should not directly work in storage areas where medicinal products with open packaging materials are handled.
1.7. Personnel working in storage areas shall wear garments suitable for the activities that they perform.
2. Premises and facilities
2.1. Warehouses should be built at a dry, airy and safe place and have a drainage system to ensure that medicinal products and materials are protected from underground water, heavy rain, and flood.
2.2. Warehouses should be designed, constructed, equipped, repaired and maintained in such a systematic manner as to protect medicinal products from all potentially harmful influences such as undue variations of temperature and humidity; dust and odor; entry of animals, vermin and insects, and to avoid affecting quality of medicinal products.
Ceilings, walls and roofs of warehouses must be sturdy, airy, and able to withstand weather impacts such as sunlight, rain, storm and flood.
The ground of a warehouse must be adequately elevated, flat, smooth and hard. There should be no cracks which are places for dust and insects.
2.3. A warehouse must be wide enough to create space for the following operations:
- Receipt and inspection of receipt of medicinal products;
- Storage of medicinal products;
- Storage of medicinal products requiring special storage conditions;
- Storage of medicinal products that must be under special control or separately stored;
- Quarantine of products awaiting handling (in case products are returned, recalled or suspected to be counterfeit or any doubt arises over their quality, etc.);
- Preparation, packaging and issue of medicinal products;
2.4. Areas of the warehouse should have signs clearly indicating capacity of each area, have appropriate size and volume and provide enough space to allow categorization and arrangement of medicinal products and materials by their type and separation of each type and batch to ensure air circulation.
2.5. Appropriate vehicles and equipment should be in place to ensure good storage conditions (e.g. ventilation fans, air-conditioning thermometers, trucks, forklifts, hygrometers, cold rooms, refrigerators, vaccine vial monitors, freeze tags, etc.). Equipment should be periodically inspected, serviced and maintained to ensure its stable and accurate operation. Measuring instruments should be periodically calibrated in accordance with regulations of law on verification and calibration of measuring instruments.
2.6. There should be devices (such as bells, lights and/or messages) that automatically detect and notice emergencies or deviations from storage conditions, especially in case of medicinal products requiring special storage conditions (temperature).
2.7. Adequate lighting should be provided to enable all operations to be carried out accurately and safely. Medicinal products should be protected from direct sunlight.
2.8. There should be enough pallets. Distance between pallets and between pallets and warehouse ground should be wide enough to permit cleaning, inspection, loading and unloading.
2.9. There should be enough firefighting equipment and firefighting precautions, such as automatic firefighting system, fire extinguishers, sand barrels and water and fire hose system.
2.10. Washing and toilet facilities should be well-ventilated and suitably spaced (isolated from medicinal product reception, storage and handling areas).
2.11. Regulations on entry into storage areas must be available and precautions must be taken to prevent unauthorized persons from entering storage areas.
3. Storage of medicinal products
3.1. Medicinal products should be stored in conditions which assure that their quality is maintained. The “First Expires First Out” (FEFO) or “First In First Out” (FIFO) principle should be followed.
3.2. Medicinal products should be placed on pallets and panels and stored off the floor. Medicinal product packaging and containers may be stacked but measures should be in place to prevent any spillage or damage to lower packaging and containers.
3.3. Medicinal product containers should remain intact during storage. Do not use container of one product for another.
3.4. Receiving and dispatch bays should protect medicinal products from the weather.
3.5. There should be measures against loss of special-controlled medicinal products prescribed in the Circular No. 20/2017/TT-BYT and the following measures:
a) Storage areas of special-controlled medicinal products should have signs clearly indicating each type of corresponding special-controlled medicinal products.
b) Toxic medicinal products should be packaged in such a manner as to prevent permeation and leakage during transportation.
3.6. Highly active medicinal products (sexual hormone, cytotoxics, etc.), highly sensitive medicinal products (beta-lactam antibiotics, etc.), products presenting special risks of abuse, fire or explosion (e.g. combustible or flammable liquids and solids and pressurized gases) should be stored in a dedicated area(s) that is subject to appropriate additional safety and security measures in accordance with regulations of relevant legislative documents.
3.7. Odorous medicinal products should be stored in tightly closed packaging materials in dedicated area(s) to prevent odor from other medicinal products.
3.8. Light-sensitive medicinal products should be stored in closed packaging materials, in enclosed spaces or dark rooms.
3.10. Measures should be in place to physically isolate quarantine areas in a warehouse. Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel.
3.11. Broken or damaged items should be withdrawn from usable stock and separated.
Broken or leaked products should be cleaned up as soon as possible to avoid contamination, cross-contamination and harm to other products or personnel. Documented procedures should be in place to deal with such issues.
Storage conditions
3.12. Storage conditions for medicinal products should be in compliance with the labeling that has been approved or published as prescribed.
3.14. Storage instructions:
a) Normal storage conditions:
It is required to store products in dry (humidity 75%), well-ventilated premises at temperatures of 15 - 30°C or, depending on climatic conditions, up to 30°C, but not exceeding 32°C and humidity must not exceed 80%. Extraneous odors, other indications of contamination, and intense light must be excluded.
If the label does not specify storage conditions, store at room temperature.
b) Special storage conditions: Medicinal products that must be stored under defined conditions require appropriate storage instructions.
c) Defined storage instructions:
|
On the label |
Means |
|
“Do not store over 30°C” |
from +2°C to +30°C |
|
“Do not store over 25°C” |
from +2°C to +25°C |
|
“Do not store over 15°C” |
from +2°C to +15°C |
|
“Do not store over 8°C” |
from +2°C to +8°C |
|
“Do not store below 8°C” |
from +8°C to +25°C |
|
“Cold storage” |
from +2°C to +8°C |
|
“Cool storage” |
from +8°C to +15°C |
|
“Dry”, “Protect from moisture” |
no more than 75% relative humidity in normal storage conditions; or to be provided to the patient in a moisture-resistant container. |
|
“Protect from light” |
to be provided to the patient in a light-resistant container |
3.15. Storage conditions should be checked at suitable predetermined intervals (at least twice per day). The results of such checks should be recorded and retained. Records of storage condition monitoring data should be available for review.
3.16. It is recommended that equipment used for monitoring of storage conditions during storage and transportation be located in areas that are most likely to show fluctuations, determined according to the results obtained from temperature mapping studies.
3.17. Narcotic drugs, psychotropic drugs, precursors and medicinal materials that are narcotic active ingredients, psychotropic drugs and precursors should be stored in separate warehouses/cabinets as prescribed in Article 4 of the Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health.
- Combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors should be stored in separate warehouses/cabinets or separate areas as prescribed in Article 4 of the Circular No. 20/2017/TT-BYT dated May 10, 2017 of the Minister of Health.
- Toxic medicinal products and medicinal products on the List of medicinal products banned from certain fields should be stored in separate areas and packaged in such a manner as to prevent permeation and leakage of toxic medicinal products during their transport.
3.18. Medicinal products requiring monitoring of temperature, humidity and light (vaccines, products requiring cold storage or deep freezing, etc.) should be stored in cold storage warehouses or refrigerators with appropriate volume. Cold storage warehouses or refrigerators should ensure uniform temperature within the permissible range. It is recommended that temperature monitors be located in areas that are most likely to show fluctuations according to the results of temperature mapping of cold storage warehouses/refrigerators, including at least 01 temperature monitor capable of automatically recording temperature data at suitable recording intervals (01 or 02 times within 01 hour, depending on season).
There should be devices (such as bells and lights) that promptly detect and notice emergencies or deviations from storage conditions (temperature, humidity).
3.19. Temperature mapping of storage areas should be carried out in accordance with WHO guidance for the temperature mapping of storage areas. Temperature mapping should show uniformity of the temperature across the storage facility.
3.20. Vaccines should be arranged in accordance with Guidance for the storage of vaccines enclosed with the Decision No. 1730/QD-BYT dated May 16, 2014 of the Minister of Health.
Stock rotation and control
3.21. Periodic stock reconciliation should be performed by comparing the actual and recorded stocks. In any case, the comparison shall be made as soon as each batch is used up.
3.22. All significant stock discrepancies should be investigated as a check against inadvertent mix-ups and/or incorrect issue. Investigation records should be retained.
3.23. In case medicinal product containers are damaged or their labels are lost/torn/unclear or any doubt arises over their quality, they should not be issued. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented.
4. Receipt of incoming medicinal products
4.1. It is required to adopt regulations and measures to ensure that appropriate medicinal products are sourced only from approved suppliers and distributed by approved entities.
4.2. On receipt, each incoming delivery should be checked against the relevant purchase order and each container physically verified, e.g. by the label description, batch number, type of medicinal product or material and quantity. The consignment should be examined for uniformity of the containers and, if necessary, should be subdivided according to the supplier’s batch number.
4.3. Each container should be carefully inspected for possible contamination, tampering and damage, and any suspect containers or, if necessary, the entire delivery should be quarantined for further investigation. Where possible, this should be brought to the attention of the person responsible for quality control. Any action taken should be documented. All containers of medicinal products that are damaged, have lost their seals or are suspected of contamination should not be received. If not destroyed immediately, they should be stored in quarantine areas and should not be sold or mixed up with other medicinal products.
4.4. Measures should be taken to ensure that rejected medicinal products cannot be used. They should be stored separately from other medicinal products and materials while awaiting destruction or return to the supplier.
5. Issue
5.2. Only medicinal products that meet quality standards and are unexpired should be dispatched and issued.
5.3. Medicinal products in quarantine shall be allowed for dispatch by the competent person.
6. Documentation
6.1. Written standard operating procedures and records which document all activities performed in warehouses should be available. At least the following procedures should be established:
- Procedures for receipt of medicinal products and inspection of received medicinal products
- Procedures for storage of medicinal products in warehouses
- Procedures for inspection and monitoring of medicinal product quality in warehouses
- Warehouse cleaning procedures
- Procedures for inspection, servicing and maintenance of storage equipment
- Procedures for control of molds, fungi, termites, insects and other animals in warehouse
- Procedures for handling of damaged and broken medicinal products
- Storage condition monitoring and recording procedures
- Issue procedures
- Returned medicinal products receipt and handling procedures
- Quarantine procedures
- Procedures for periodic comparison of medicinal products in warehouses.
6.2. All documents and procedures should have unambiguous and clear content, be easily implemented and approved by a competent person. Documents should be regularly reviewed and kept up-to-date.
6.3. All records should be retained for review and measures should be in place to avoid damage and/or loss, unauthorized use, destruction or correction of data.
6.4. Regulations on period of retention of records should be complied with. Otherwise such records should be retained for at least 01 (one) year after the expiry date of the batch of medicinal products.
6.5. Documents about narcotic drugs, psychotropic drugs, precursors; combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors; toxic medicinal products and medicinal products on the List of medicinal products banned from certain fields shall comply with regulations of relevant legislative documents.
6.6. It is recommended to use computers connected to the Internet and manage storage of medicinal products using software. Transfer information about receipt and issue of medicinal products to a customer, and quality information between a manufacturer and a customer, as well as the transfer of information to the relevant regulatory authority as required.
7. Returned and recalled medicinal products
7.1. Returned medicinal products should be stored in separate areas and labeled as returned products. They should be only re-issued after having their quality and safety considered and evaluated.
7.2. All returned medicinal products which are evaluated that they fail to meet quality and safety standards should be handled in accordance with regulations of law.
7.3. Medicinal products that are recalled according to the notification given by the regulatory authority, manufacturer or supplier should not be issued and should be stored in quarantine areas and labeled as recalled products. The particular storage conditions applicable to a medicinal product which is subject to recall should be maintained during storage and transit until such time as a decision has been made regarding the fate of the product in question.
8. Self-inspection
8.1. Self-inspections should be conducted in an independent and detailed way by a designated, competent person.
8.2. The results of all self-inspections should be recorded. Reports should contain all observations made during the inspection and, where applicable, proposals for corrective measures (if any). There should be an effective follow-up program. Management should evaluate the inspection report and the records of any corrective actions taken.
APPENDIX V
CLASSIFICATION OF DEFICIENCIES AND COMPLIANCE WITH GOOD STORAGE PRACTICES FOR MEDICINAL PRODUCTS AND MEDICINAL MATERIALS BY MEDICINAL PRODUCT AND MEDICINAL MATERIAL STORAGE FACILITIES
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
I. Classification of deficiencies
1) Critical deficiency means a deviation from GSP, resulting in producing a medicinal product or medicinal material in a manner that adversely affects the quality, safety and efficacy and leading to a risk of seriously affecting life and health of the user or community; or means a combination of several major deficiencies, which indicates a serious system failure. It includes fraud, misrepresentation or falsification of data.
2) Major deficiency means a non-critical deficiency but may lead to the storage of medicinal products and materials being out of compliance with storage guidelines of the manufacturer; or indicates a major deviation from GSP or storage conditions; or indicates a failure to carry out satisfactory storage procedures or a failure of the qualified person to fulfill his/her legal duties; or means a combination of several “other” deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such.
3) Minor deficiency means a deficiency, which cannot be classified as either critical or major one, but which indicates a deviation from GSP.
II. Classification of GSP compliance
1) Level 1: the facility does not have any critical and major deficiencies.
2) Level 2: the facility does not have any critical deficiencies and has major deficiencies.
3) Level 3: the facility has critical deficiencies.
APPENDIX VI
SITE MASTER FILE OF MEDICINAL PRODUCT AND MEDICINAL MATERIAL STORAGE FACILITIES
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
I - Introduction
II - Content of Site Master File
1. General information on the facility
2. Quality management system
3. Personnel
4. Premises and equipment
5. Documentation
6. Storage
7. Complaints, product defects and recalls
8. Self inspections
I - INTRODUCTION
The Site Master File (SMF) is prepared by the medicinal product and medicinal material storage facility and should contain specific information about the quality management policies and storage and control of quality of medicinal products and medicinal materials and other relevant activities carried out at the facility.
When submitted to a regulatory authority, the Site Master File should provide clear information on the facility’s storage related activities that can be useful in general supervision and in the efficient planning and undertaking of GSP inspections.
A Site Master File should contain adequate information but, as far as possible, not exceed 25-30 pages plus appendices. Simple plans outline drawings or schematic layouts are preferred instead of narratives. The Site Master File, including appendices, should be readable when printed on A4 paper sheets.
The Site Master File should be a part of documentation belonging to the quality management system of the facility and kept updated accordingly. The Site Master File should have an edition number, the date it becomes effective and the date by which it has to be reviewed. It should be subject to regular review to ensure that it is up to date and representative of current activities.
Each Appendix can have an individual effective date, allowing for independent updating.
Historical file shall be treated as part of the Site Master File, including summary of changes in content of the site master file and appendices, plus date of change and reason for change.
II - CONTENT OF SITE MASTER FILE
1. General information on the facility
1.1. Contact information on the facility
- Name and official address of the facility;
- Names and street addresses of the warehouses where medicinal products and medicinal materials are stored;
- Contact information of the facility including 24 hrs telephone number of the contact personnel in the case of product defects or recalls;
- Identification number of the site as e.g. GPS details, or any other geographic location system.
1.2. Authorized activities of the facility
- Copy of the valid certificate of eligibility for business issued by the relevant Competent Authority in Appendix I.
- Brief description of the import, export, storage and other activities as authorized by the relevant Competent Authorities including foreign authorities with authorized activities, respectively where not covered by the certificate of eligibility for medicinal product business.
- Type of products and materials currently stored on-site (list in Appendix II) where not covered by Appendix I.
- List of GSP inspections of the site within the last 5 years; including dates and name of the Competent Authority having performed the inspection. A copy of current GSP certificate (Appendix III), if available.
1.3. Any other activities carried out at the facility
- Description of non-pharmaceutical activities on-site, if any.
2. Quality management system
2.1. Quality management system of the facility
- Brief description of the quality management systems run by the facility and reference to the standards used;
- Responsibilities related to the maintaining of quality system including senior management;
- Information of activities for which the site is accredited and certified, including dates and contents of accreditations, names of accrediting bodies.
2.2. Management of suppliers and contractors
- A brief summary of the establishment/knowledge of supply chain and the external audit program;
- Brief description of the qualification system of other critical contractors and suppliers;
- Brief overview of the responsibility sharing between the contract giver and acceptor with respect to compliance with regulations on quality assurance.
2.3. Quality Risk Management (QRM)
- Brief description of QRM methodologies used by the facility;
- Scope and focus of QRM including brief description of any activities which are performed at corporate level, and those which are performed locally. Any application of the QRM system to assess continuity of supply should be mentioned.
3. Personnel
- Organization chart showing the arrangements for quality management, production and quality control positions/titles, including senior management and Qualified Person(s);
- Number of employees engaged in the quality management and storage.
4. Premises and equipment
4.1. Premises
- Short description of the facility: size of the facility/storage area and list of buildings. If the storage of medicinal products and materials takes place in different buildings on the facility, the buildings should be listed with destined medicinal products and materials identified (if not identified under 1.1);
- Simple description of storage areas (architectural or engineering drawings are not required);
- Lay-outs and storage areas, with special areas for the storage and handling of highly toxic, hazardous and sensitizing materials indicated, if applicable;
- Brief description of specific storage conditions if applicable but not indicated on the lay-outs;
4.1.1. Brief description of heating, ventilation and air conditioning (HVAC) system
- Principles for defining the air supply, temperature, humidity, policy of air recirculation (%).
4.1.2. Brief description of other relevant utilities
4.2. Equipment
4.2.1. Major equipment
Listing of major production and control laboratory equipment with critical pieces of equipment identified should be provided in Appendix VIII.
4.2.2. Cleaning and sanitation
Brief description of cleaning and sanitation methods of product contact surfaces (i.e. manual cleaning, automatic Clean-in-Place, etc).
4.2.3. Computerized systems
5. Documentation
- Description of documentation system (i.e. electronic, manual);
- When documents and records are stored or archived off-site: List of types of documents/records; Name and address of storage site and an estimate of time required retrieving documents from the off-site archive.
6. Storage
6.1. Products and materials stored
Refer to Appendix I and Appendix II.
- Types of products and materials stored at the facility.
- Toxic or hazardous substances stored (e.g. with high pharmacological activity and/or with sensitizing properties);
6.2. Qualification, calibration
- Brief description of policy for qualification of temperature uniformity and humidity; calibration of temperature and humidity measuring, control and monitoring equipment.
7. Complaints, product defects and recalls
7.1. Handling complaints
Brief description of the system for handling complains.
7.2. Handling product defects
Brief description of the system for handling product defects.
7.3. Recalls
Brief description of the system for recalling products.
8. Self inspections
Short description of the self inspection system with focus on criteria used for selection of the areas to be covered during planned inspections, practical arrangements and follow-up activities.
Appendix I: Copy of valid operation license.
Appendix II: List of products and materials stored.
Appendix III: Copy of the certificate of eligibility for pharmacy business. (or legal documents about establishment, functions and tasks of the non-commercial facility)
Appendix IV: List of contract facilities (including the addresses and contact information for outsourced activities).
Appendix V: Organizational charts.
Appendix VI: Lay outs of storage areas.
Appendix VII: Chart of air principles of the central heating, ventilation and air conditioning (HVAC) system.
Appendix VIII: List of equipment.
APPENDIX VII
DOCUMENT TEMPLATE
(Enclosed with the Circular No. 36/2018/TT-BYT dated November 22, 2018 of the Minister of Health)
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NAME OF THE MANAGING ENTITY |
THE SOCIALIST REPUBLIC OF VIETNAM |
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No. ….…/…. |
.........(Place name), date (dd/mm/yyyy) … |
NOTIFICATION OF GSP COMPLIANCE
To: Drug Administration of Vietnam / Traditional Medicine Administration of Vietnam - Ministry of Health / Department of Health of … province/city
Name of the facility: ………………………………………………………………………
Address of the warehouse: ……………………………………………………………
Telephone: …………………. Fax: …………… Email: ………………………
Contact person: ………………………………… Title: ………………
Telephone: …………………. Fax: …………… Email: ………………………
Chief pharmacist: ……………………, year of birth: ………
Pharmacy practicing certificate No. ………………….………………………………
Place of issue……………………; date of issue ………, expiry date ……… (if any)
Our facility was established in accordance with the Decision No. … dated …/…/…… of ……on functions and tasks of……, which allows provision of medicinal product and medicinal material storage services. To be specific:
……………………………………………………………………………………
……………………………………………………………………………………
Complying with regulations of the Law on Pharmacy and Circular No. ....../2018/TT-BYT dated …, 2018 of the Ministry of Health on Good Storage Practices for medicinal products and medicinal materials, after conducting a self-inspection and self-assessment, we would like to send a notification of GSP compliance.
We are committed to complying with all regulations of legal documents and relevant pharmacy regulations.
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Head of the facility |
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NAME OF THE MANAGING ENTITY |
THE SOCIALIST REPUBLIC OF VIETNAM |
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No. ….…/…. |
.........(Place name), date (dd/mm/yyyy) … |
REPORT ON STORAGE OF MEDICINAL PRODUCTS AND MEDICINAL MATERIALS AND GSP COMPLIANCE
To: Drug Administration of Vietnam / Traditional Medicine Administration of Vietnam - Ministry of Health
I. GENERAL INFORMATION ON THE STORAGE FACILITY
- Name of the facility: ………………………………………………………………………
- Legal address: ……………………………………………………………
Telephone: …………………. Fax: …………… Email: ……………………
- Address of the inspected facility: ……………………………………………………………
Telephone: …………………. Fax: …………… Email: ……………………
- Business registration certificate/Investment registration certificate No. ……..
- Certificate of eligibility for pharmacy business No. ………, date of issue: ………
- Legal representative: ……………………………………………………..
- Chief pharmacist: …………………………………………
Pharmacy practicing certificate No. ………………….………………………………
Scope: ……………………………………………………………………….
Date of issue: ………………………… Place of issue: ………………………………….
II. REPORT ON STORAGE OPERATIONS AND GSP COMPLIANCE
Implementing the Circular No. ....../2018/TT-BYT dated …, 2018 of the Ministry of Health on Good Storage Practices for medicinal products and medicinal materials and updated documents, within the last 3 years, from the inspection of GSP compliance conducted on………, we have strictly complied with GSP requirements and maintains compliance with GSP requirements applicable to storage operations covered by the certificate. To be specific:
1. Personnel and training
1.1. Quantity and qualifications of personnel
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Qualification Department |
Postgraduate degree |
Bachelor's degree in pharmacy |
Other undergraduate degree in pharmacy |
Intermediate professional education diploma in pharmacy |
Other |
Total |
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Management department |
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Warehousing department |
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Support department (M&E, etc.) |
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Total |
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1.2. Training
Number of annual training courses on GSP and relevant issues.
2. Storage
2.1. Storage operations:
Number of batches of products stored each year and categorized by groups of products within the scope of the certificate: (made into a separate appendix)
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No. |
Name of medicinal product |
Number of Certificate of registration/ Number of import license |
Active ingredient, concentration |
Dosage form |
Name of manufacturer |
Manufacturing country |
Storage conditions |
Special-controlled medicinal product* (if any) |
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* Note: Specify each group of special-controlled medicinal products (specified in abbreviations)
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Special-controlled medicinal product |
Abbreviation |
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Narcotic drugs |
GN |
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Psychotropic drugs |
HT |
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Precursors |
TC |
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Radiopharmaceuticals |
PX |
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Combined drugs that contain narcotic active ingredients |
PHGN |
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Combined drugs that contain psychotropic active ingredients |
PHHT |
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Combined drugs that contain psychotropic active ingredients |
PHTC |
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Toxic medicinal products |
Toxic |
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Medicinal products on the List of medicinal products banned from certain fields and active ingredients on the List of substances banned from certain fields |
Banned |
2.2. Processing:
Number of batches of medicinal products and medicinal materials under secondary labeling outsourcing agreement.
3. Quality management
3.1. Batches of medicinal products and medicinal materials that fail to meet quality standards:
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Product name |
Batch number, expiry date |
Reasons |
Notes |
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Fail criteria? result? Detected through inspection of quality during storage? Samples collected on the market? Sampling unit? testing unit? |
Recall method: voluntary? compulsory? Handling status (destruction, isolation)? Investigation of reasons? Corrective actions? |
3.2. Batches of medicinal products and materials against which complaints are filed and which are returned:
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Product name |
Batch number, expiry date |
Reasons |
Notes |
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Handling methods? Handling status (destruction, isolation)? Investigation of reasons? Corrective actions? |
4. Self inspections
Number of self-inspections conducted each year.
Number of self-inspections conducted at the facility by other regulatory authorities.
5. Changes (if any)
5.1. Premises, auxiliary system:
- Construction and arrangement of warehouses;
- Capacity/purpose of storage rooms/areas;
- Auxiliary system serving storage operations.
Change control methods applied to those changes (re-assessment, change of procedures, re-training, etc.).
5.2. Personnel:
Changes of key personnel.
5.3. Equipment:
Changes (if any) of quantity, type, location and purposes, auxiliary system (cooling, supplied air treatment, exhaust gas treatment, etc.) of equipment serving storage operations;
Change control methods applied to those changes (re-assessment, change of procedures, re-training, etc.).
6. Enclosed appendices
In order to provide information about current condition of the facility in a sufficient, detailed and updated manner, we would like to enclose an updated site master file with this report.
III. CONCLUSION
We hereby take legal responsibility for the accuracy and truthfulness of the report and enclosed documents.
We hereby agree of our free will to submit to the GSP compliance inspection by the Ministry of Health (Drug Administration of Vietnam/Traditional Medicine Administration of Vietnam) according to the certificate of GSP compliance.
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Head of the facility |
• Name of the inspected facility:
• Address of the inspected facility:
• Scope of inspection:
• Method of inspection:
• Date of inspection:
I. MEMBERS OF THE INSPECTORATE
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No. |
Full name |
Position |
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1. |
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Chief |
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2. |
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Member |
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3. |
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Member |
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4. |
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Member |
II. FACILITY’S PERSONNEL JOINING THE INSPECTORATE
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No. |
Full name |
Position |
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III. DISAGREEMENTS BETWEEN THE FACILITY AND THE INSPECTORATE
……………………………………………………………………………………
……………………………………………………………………………………
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Chief of the inspectorate |
Representative of the facility |
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THE MINISTRY OF HEALTH |
THE SOCIALIST REPUBLIC OF VIETNAM |
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(Place name), date (dd/mm/yyyy) … |
I. GENERAL INFORMATION ON THE FACILITY
- Name of the facility: ...
- Address of the inspected facility: …
- Telephone: …
- Business registration certificate/Investment registration certificate No. …
- Legal representative: ...
- Chief pharmacist: ...
II. GENERAL INFORMATION ON THE INSPECTION
- Date of inspection: ….
- Latest inspection: …
- Method of inspection: …
- Scope of inspection: …
III. INFORMATION ON THE INSPECTORATE
- Inspectorate establishment decision No. …
- Members of the inspectorate: …
IV. SITE INSPECTION
1. Organization and management
2. Personnel
3. Quality system
4. Premises and equipment
5. Storage of medicinal products and medicinal materials
6. Receipt
7. Dispatch and transport
8. Procedures and documentation
9. Returned goods
10. Recalls
11. Self inspections
V. LIST OF DEFICIENCIES
Reference: …
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No. |
Deficiencies |
Reference |
Level |
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1. |
Organization and management |
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1.1. |
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2. |
Personnel |
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2.1. |
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3. |
Quality system |
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3.1. |
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4. |
Premises and equipment |
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4.1. |
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5. |
Storage of medicinal products and medicinal materials |
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5.1. |
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6. |
Receipt |
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6.1. |
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7. |
Dispatch and transport |
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7.1. |
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8. |
Procedures and documentation |
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8.1. |
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9. |
Returned goods |
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9.1. |
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10. |
Recalls |
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10.1. |
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11. |
Self inspections |
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11.1. |
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Total deficiencies: Critical: 0 Major: 0 Minor: 0 Recommendations: 0 |
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VI. CONCLUSIONS GIVEN BY THE INSPECTORATE
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Chief of the inspectorate |
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BỘ Y TẾ |
CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM |
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Số / No.: ………./GCN-QLD |
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GIẤY CHỨNG NHẬN ĐÁP ỨNG THỰC HÀNH TỐT BẢO QUẢN THUỐC, NGUYÊN LIỆU LÀM THUỐC (GSP)
Phần 1/ Part 1 :
Ban hành theo quy định tại Thông tư số …/2018/TT-BYT ngày …/…/2018 của Bộ Y tế Việt Nam, Cục Quản lý Dược chứng nhận:
Issued in accordance with Circular .../2018/TT-BYT dated .../.../2018 by Vietnam Ministry of Health, the Drug Administration//Traditional medicine Administration confirms the following:
Cơ sở bảo quản: …………………………………………………………
Địa chỉ văn phòng: …………………………………………………………
Địa chỉ kho bảo quản: …………………………………………………………
The establisment: ………………………………………………………………
Legal address: ………………………………………………………………
Site address: ………………………………………………………………
Đã được đánh giá theo quy định của nhà nước liên quan đến Giấy chứng nhận đủ điều kiện kinh doanh dược số ……………, theo quy định tại Thông tư số …/2018/TT-BYT ngày …/…/2018 của Bộ Y tế Việt Nam; Và/hoặc quy định khác: ………………………………………….
Has been inspected under the national regulation in connection with pharmaceutical business license No. …………………, in accordance with Circular …/2018/TT-BYT dated …/…/2018 by Vietnam Ministry of Health; And/or other legal document: …………………………
Căn cứ kết quả đánh giá cơ sở bảo quản được thực hiện ngày …/…/…, cơ sở bảo quản nêu trên được công nhận đáp ứng tiêu chuẩn Thực hành tốt bảo quản thuốc, nguyên liệu làm thuốc (GSP) theo theo quy định tại Thông tư số …/2018/TT-BYT ngày …/…/2018 của Bộ Y tế Việt Nam, phù hợp với hướng dẫn GSP của Tổ chức Y tế thế giới.
From the knowledge gained during inspection of this establisment, which was conducted on …/…/…, it is considered that it complies with the requirements of Good Storage Practice for medicinal products and medicinal materials laid down in Circular …/2018/TT-BYT dated …/…/2018 by Vietnam Ministry of Health, which is harmonized with the requirements of GSP guideline of World Health Organization.
Giấy chứng nhận này thể hiện tình trạng tuân thủ GSP của cơ sở bảo quản tại thời điểm đánh giá nêu trên và có hiệu lực không quá 3 năm kể từ ngày đánh giá. Tuy nhiên, căn cứ theo nguyên tắc quản lý rủi ro, thời gian hiệu lực của Giấy chứng nhận có thể được rút ngắn hoặc kéo dài và được ghi tại mục Những nội dung hạn chế hoặc làm rõ.
This certificate reflects the status of the warehousing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field.
Giấy chứng nhận chỉ có hiệu lực khi thể hiện đầy đủ các trang và bao gồm cả Phần 1 và Phần 2.
This certificate is valid only when presented with all pages and both Part 1 and Part 2.
Tính xác thực của Giấy chứng nhận này có thể được xác nhận thông qua nội dung đăng tải trên trang thông tin điện tử của Cục Quản lý Dược Việt Nam / Cục Quản lý Y, Dược cổ truyền. Nếu không có, hãy liên hệ với Cục Quản lý Dược / Cục Quản lý Y, Dược cổ truyền Việt Nam để được làm rõ.
The authenticity of this certificate may be verified in website of the Drug Administration of Vietnam / Traditional medicine Administration of Vietnam. If it does not appear, please contact the Drug Administration / Traditional medicine Administration of Vietnam.
Phần 2 / Part 2 :
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1. HOẠT ĐỘNG BẢO QUẢN THUỐC STORAGE OPERATIONS – MEDICINAL PRODUCTS |
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1.1 |
Thuốc hóa dược chứa kháng sinh nhóm β-Lactam / Chemical medicinal products containing β-Lactam antibiotics |
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1.1.1. Thuốc bảo quản ở điều kiện thường / Normal storage condition. |
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1.1.2. Thuốc bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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1.1.3. Thuốc bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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1.2 |
Thuốc hóa dược không chứa kháng sinh nhóm β-Lactam / Chemical medicinal products not containing β-Lactam antibiotics |
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1.2.1. Thuốc bảo quản ở điều kiện thường / Normal storage condition. |
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1.2.2. Thuốc bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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1.2.3. Thuốc bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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1.3 |
Thuốc dược liệu / Herbal medicinal products |
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1.3.1. Thuốc bảo quản ở điều kiện thường / Normal storage condition. |
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1.3.2. Thuốc bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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1.3.3. Thuốc bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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1.4 |
Thuốc sinh học / Biological medicinal products |
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1.4.1. Thuốc bảo quản ở điều kiện thường / Normal storage condition. |
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1.4.2. Thuốc bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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1.4.3. Thuốc bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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1.5 |
Thuốcấphải kiểm soát đặc biệt / Special-controlled medicinal products |
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1.5.1. Thuốc bảo quản ở điều kiện thường / Normal storage condition. |
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1.5.2. Thuốc bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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1.5.3. Thuốc bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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2. HOẠT ĐỘNG BẢO QUẢN NGUYÊN LIỆU LÀM THUỐC STORAGE OPERATIONS – MEDICINAL MATERIALS |
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2.1 |
Nguyên liệu kháng sinh nhóm β-Lactam / β-Lactam antibiotics materials |
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2.1.1. Nguyên liệu bảo quản ở điều kiện thường / Normal storage condition. |
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2.1.2. Nguyên liệu bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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2. HOẠT ĐỘNG BẢO QUẢN NGUYÊN LIỆU LÀM THUỐC STORAGE OPERATIONS – MEDICINAL MATERIALS |
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2.1.3. Nguyên liệu bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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2.2 |
Nguyên liệu hóa dược khác / Other chemical medicinal materials |
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2.2.1. Nguyên liệu bảo quản ở điều kiện thường / Normal storage condition. |
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2.2.2. Nguyên liệu bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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2.2.3. Nguyên liệu bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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2.3 |
Nguyên liệu dược liệu / Herbal medicinal materials |
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2.3.1. Nguyên liệu bảo quản ở điều kiện thường / Normal storage condition. |
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2.3.2. Nguyên liệu bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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2.3.3. Nguyên liệu bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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2.4 |
Nguyên liệu sinh học dùng làm thuốc / Biological medicinal materials |
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2.4.1. Nguyên liệu bảo quản ở điều kiện thường / Normal storage condition. |
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2.4.2. Nguyên liệu bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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2.4.3. Nguyên liệu bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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2.5 |
Nguyên liệu phải kiểm soát đặc biệt / Special-controlled medicinal materials |
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2.5.1. Nguyên liệu bảo quản ở điều kiện thường / Normal storage condition. |
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2.5.2. Nguyên liệu bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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2.5.3. Nguyên liệu bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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2.6 |
Nguyên liệu khác: … / Other medicinal materials: … |
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2.6.1. Nguyên liệu bảo quản ở điều kiện thường / Normal storage condition. |
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2.6.2. Nguyên liệu bảo quản ở điều kiện lạnh / Cold storage condition : 2 – 8 °C |
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2.6.3. Nguyên liệu bảo quản ở điều kiện khác / Other storage conditions : ………………………………………………………………………………… |
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Nội dung hạn chế hoặc làm rõ liên quan đến phạm vi chứng nhận :
Any restrictions or clarifying remarks related to the scope of this certificate :
……………………………………………………………………………………
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… / … / …… |
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NAME OF THE MANAGING ENTITY |
THE SOCIALIST REPUBLIC OF VIETNAM |
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No. ….…/…. |
.........(Place name), date (dd/mm/yyyy) … |
REPORT ON CHANGES RELATED TO GSP
To: Drug Administration of Vietnam / Traditional Medicine Administration of Vietnam - Ministry of Health
Name of the facility: ………………………………………………………………………
Address of the warehouse: ……………………………………………………………
Telephone: …………………. Fax: …………… Email: ………………………
Contact person: ………………………………… Title: ………………
Telephone: …………………. Fax: …………… Email: ………………………
Chief pharmacist: ……………………, year of birth: ………
Pharmacy practicing certificate No. ………………….………………………………
Place of issue……………………; date of issue ………, expiry date ……… (if any)
Has been granted the Certificate of eligibility for pharmacy business No. ………, date of issue: ………, which allows:
……………………………………………………………………………………
…………………………………………………………………………………… We would like to report the following changes:
……………………………………………………………………………………
……………………………………………………………………………………
List of documents about changes (depending on type of change, enclosed with corresponding documents).
After considering the Law on Pharmacy and other regulations on pharmacy practice, we are committed to comply with regulations of legal documents and relevant pharmacy regulations. We kindly request the Drug Administration of Vietnam (or Traditional Medicine Administration of Vietnam) to consider inspecting GSP compliance with respect to the abovementioned changes.
The following documents are enclosed with this report:
1. A copy of the Certificate of eligibility for pharmacy business (or Certificate of GSP compliance granted to the non-commercial facility);
2. A copy of the business registration certificate (or legal document about the establishment and functions and tasks of the non-commercial facility) (relevant to amendments);
3. Updated site master file.
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Head of the entity |