Chương VI Thông tư 36/2018/TT-BYT: Đoàn đánh giá việc đáp ứng thực hành tốt bảo quản thuốc, nguyên liệu làm thuốc

Chapter VI

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.