Thông tư 07/2012/TT-BNNPTNN đăng ký, kiểm tra, chứng nhận cơ sở sản xuất thuốc

CIRCULAR

PROCEDURES FOR REGISTRATION, INSPECTION, AND CERTIFICATION OF ADHERENCE TO GOOD MANUFACTURING PRACTICE (GMP) OF MANUFACTURERS OF VETERINARY DRUGS

Pursuant to the Ordinance on Veterinary Medicine dated April 29, 2004;

Pursuant to the Government's Decree No. 33/2005/ND-CP dated March 15, 2005 on guidelines for the Ordinance on Veterinary Medicine;

Pursuant to the Government's Decree No. 01/2008/ND-CP dated January 03, 2008, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural development; Pursuant to the Government's Decree No. 75/2009/ND-CP dated September 10, 2009 on amendments to Article 3 of the Government's Decree No. 01/2008/ND-CP;

The Ministry of Agriculture and Rural Development promulgates a Circular on procedures for registration, inspection, and certification of adherence to GMP regulations of manufacturers of veterinary drugs.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1. This Circular deals with the procedure for for registration, inspection, and certification of adherence to GMP regulations of manufacturers of veterinary drugs.

2. This Circular is applied to Vietnamese and foreign organizations engaged in veterinary manufacture in Vietnam.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. GMP is the English abbreviation of Good Manufacturing Practice, which consists of the principles, regulations, and guidelines for the manufacture conditions that applied to manufacturers of pharmaceuticals, cosmetics, etc. in order to ensure the quality and safety of products.

2. GMP-WHO is the GMP introduced by WHO, including Good Manufacturing Practice, Good Laboratory Practice (GLP), Good Storage Practice (GSP).

3. GMP-ASEAN is the GMP introduced by ASEAN in 1996, which is applied to pharmaceuticals.

4. Abbreviations:

- HVAC: heating-ventilation-air conditioning

- AHU: Air handling unit.

- SOP: Standard Operating Procedure.

Article 3. Documents applied to issuance of GMP certificates

1. GMP-WHO guidelines.

2. GMP-ASEAN guidelines.

3. Newest documents about GMP of WHO and ASEAN.

4. Legislative documents of the Ministry of Agriculture and Rural Development on GMP.

Article 4. GMP application roadmap

1. All veterinary drug manufacturers must meet the standards of GMP.

2. GMP application roadmap

a) If GMP certificates for the manufacture lines of injectable drugs or oral liquid medicines are not obtained by December 31, 2010, the products may only be sold until December 31, 2012.

b) If GMP certificates for the manufacture lines of powdered drugs for oral administration or mixing with feeds are not obtained by December 31, 2012, the products may only be sold until December 31, 2013.

c) If GMP certificates for the manufacture lines of injectable powdered drugs are not obtained by December 31, 2012, the products may only be sold until December 31, 2014.

c) If GMP certificates for the manufacture lines of vaccinesare are not obtained by December 31, 2014, the products may only be sold until December 31, 2015.

Article 5. Fees for GMP inspection and certification

1. Any applicant for GMP inspection and certification must pay the fees imposed by the Ministry of Finance. Fees shall be wired or paid directly at Department Of Animal Health.

2. Verification fee shall be paid when the application for GMP inspection and certification is submitted.

Chapter II

APPLICATION FOR GMP INSPECTION

Article 6. Inspection methods

1. First inspections shall be carried out at the manufacturing facilities that apply for GMP inspection and certification for the first time, or at the facilities that had their GMP certificates revoked and wish to obtain another one.

2. A surprise inspection shall be carried out when any manufacturer of veterinary drugs is suspected of violating GMP, or carried out at the request of a regulatory body.

3. A reinspection shall be carried out when a GMP certificate expires.

Article 7. Entitlements to inspect and issue certificates

1. Department Of Animal Health shall receive applications for GMP inspection, establish inspectorates, carry out inspections and issue GMP certificates to satisfactory facilities.

2. The composition of the inspectorate is decided by the Director of Department of Animal Health, which consists of experts experienced in GMP.

Article 8. First GMP inspection

1. The facility shall manufacture at least 03 batches of drugs on every production line that need inspecting and inspect it themselves according to GMP standards, then prepare an application for GMP inspection.

The applicant shall submit 03 packages of application to Department Of Animal Health, each of which consists of:

a) A written application for GMP inspection (Appendix 01);

b) A Certificate of Business registration or a license for establishment;

c) A diagram of organizational structure of the facility specifying the names, positions, and qualifications of the persons in charge of the departments, the work experience of the persons in charge of manufacturing division, quality control division, quality assurance division, storage division, and electromechanics division;

d) The floor plan of the factory (workshop, laboratory, warehouses), including the an overall floor plan, a map showing workers’ pathway, flow charts of ingredients, packages, semi-finished products, and finished products, a diagram of water treatment and supply system serving the manufacture; a HVAC diagram (AHU distribution); a diagram indicating the levels of cleanliness of the factory; a diagram of difference in pressures, temperatures, and humidity levels between the divisions and areas; a diagram of waste treatment system; and a diagram of the fire safety system;

dd) Training programs, training documents, and documents for assessment of GMP training at the facility;

e) A list of existing equipment of the factory, including equipment for drug manufacturing, preservation, quality control (specifying their names, codes, years of manufacture, country of origin, and their conditions);

g) A list of SOP;

h) A list of articles that are manufactured or intended to be manufactures (specifying their names, active ingredients, dosage forms, and packaging);

i) A certificate of record on inspection of fire safety issued by a local competent authority;

k) An environmental impact assessment report approved by a regulatory body in charge of environment;

l) A record on internal GMP inspection, specifying the date of inspection, composition of the inspectorate, purposes of the inspection, development of the inspection, assessment of inspection result, satisfied requirements and shortcomings, suggested plans, measures, and time for elimination of such shortcomings;

m) Any facility that have just been established and registered for GMP inspection must submit a practising certificate of the owner or the person in charge of technical issues, and a practising certificate of the person in charge of the quality inspection division.

2. The application for GMP inspection must have covers and a table of contents; the parts of the application must be separated. The separated parts must be numbered to facilitate reference. Every first page of each part must be certified by the facility. The certificate of business registration, practising certificates, certification of fire safety, and environmental impact assessment report that are enclosed in the application may be:

- Original copies;

- Notarized or authenticated copies;

- Photocopies enclosed with original copies for comparison if the application is submitted directly.

3. Deadline

Within 30 working days from the receipt of the application, Department Of Animal Health shall verify it, request adjustments or additions to the application if it is not satisfactory.

Within 60 days from the receipt of the valid application, the Director of Department of Animal Health shall issue a decision to establish a GMP inspectorate, notify the inspection date to the facility, and carry out the inspection.

c) Within 10 working days from the end of the inspection, Department Of Animal Health shall issue the GMP a certificate if the result is satisfactory, or make a written response if the result is not satisfactory.

4. Inspection contents

a) During the GMP inspection, the facility must submit reports in the form of diagrams, charts, and summarized data about their operation and the application for GMP standards.

b) During the GMP inspection, the operation of the facility must be in progress.

c) All activities of the manufacturing facility according to GMP standards, the application submitted, and current technical regulations shall be inspected.

The inspection contents shall be written on the record. 01 copy of the record is kept by the facility, 02 copies of it shall be kept a Department Of Animal Health (Appendix 2).

If the facility does not concur with the opinions of inspectorate, the dissenting opinions of the facility must be written in the inspection record.

5. Processing of inspection result

a) According to the inspection record, the chief of the inspectorate shall request the Director of the Department Of Animal Health to issue the GMP certificate to the facility that meet GMP standards.

b) If the facility basically meets the GMP standards but there are still some shortcomings that canbe eliminated in a short period of time: The inspectorate shall request the facility to eliminate the shortcomings. Within 02 months from the inspection date, the facility must eliminate the shortcomings and send a written report to Department Of Animal Health. The chief of the inspectorate shall consider the report and request the Director of Department Of Animal Health to issue the GMP certificate if the facility meets the requirements.

c) If GMP standards are not met, the facility must eliminate the shortcomings. After an internal inspection, if the GMP standards are satisfied, the facility shall file the application again.

Article 9. GMP reinspection

1. 03 months before the GMP certificate expires, the manufacturing facility must make and send 03 packages of application for GMP reinspection to Department Of Animal Health, each of which consists of:

a) A written application for GMP reinspection (Appendix 01);

b) Changes of the facility over 02 years of applying GMP;

c) A report on elimination of the shortcomings found during the previous inspection;

d) A report on the training at the facility;

dd) A report on the operation of the facility over the last 02 years;

e) A list of current equipment of the factory;

g) A list of articles being manufactured;

h) A list of SOP;

i) A certificate of record on inspection of fire safety issued by a local competent authority;

k) An environmental impact assessment report approved by a regulatory body in charge of environment;

l) A record on the latest internal inspection (within 03 months) of adherence to GMP.

2. The format of documents and the deadline for response are similar to those in Clauses 2, 3, 4, and 5 Article 8 of this Circular.

Article 10. Effect of GMP certificates

Every GMP certificate is effective for 02 years from its date of issue.

Article 11. Revocation of GMP certificates

1. Every facility issued with the GMP certificate must sustain the manufacturing conditions in accordance with GMP throughout the effective period of the GMP certificate.

2. The GMP certificate shall be confiscated in the following cases:

a) A surprise inspection reveals that the facility is committing violations against GMP requirements during a surprise inspection, which seriously affect the quality of drugs.

b) The facility refuses the inspection after 02 requests are made by a competent authority.

3. The decision on revocation of GMP certificate shall be made into two copies, one of which is kept at that facility that has the certificate revoked, and the other is kept by the inspecting authority.

Chapter III

IMPLEMENTATION

Article 12. Effect

This Circular takes effect after 45 days from the day on which it is signed.

Article 13. Organization of implementation

Department Of Animal Health shall spread instructions on implementation of this Circular among the applicants for GMP inspection.

It is recommended that the difficulties that arise during the implementation of this Circular be reported to the Ministry of Agriculture and Rural Development (Department Of Animal Health) for amendments./.

FORM - APPLICATION FOR GMP INSPECTION

APPLICATION FOR GMP INSPECTION/REINSPECTION

To: Department Of Animal Health

Pursuant to the Circular No. ..... /2011/TT-BNNPTNT dated ................. of the Ministry of Agriculture and Rural Development on procedures for registration, inspection, and certification of adherence to GMP regulations of manufacturers of veterinary drugs.

1- Name of applicant:

2- Factory’s address:

3- Phone number:                             Fax:                      E-Mail:

We hereby requests Department Of Animal Health to carry out an inspection/a reinspection and issue a Certificate of conformity to GMP according to WHO/ASEAN for the following productions lines:

- Oral liquid drugs

- Injectable powders, liquids, mixtures, etc.

(non-beta lactam or beta-lactam)

Enclosed documents:

- Certificate of Business registration;

- ........;

Appendix II

GMP INSPECTION RECORD FORM

GMP INSPECTION RECORD

Pursuant to the Decision No. ........../QD-TY-QLT dated ....................... of the Director of Department of Animal Health on establishment of an inspectorate to inspect at .....................

The inspectorate is composed of:

1…............................... - Chief of the inspectorate.

2................................... - Secretary.

3....................................- Member.

4 ………………………- Member.

………………………………….

NAME OF THE FACILITY:

- Address:

- Person in charge:

- Application for GMP inspection dated .............. of ...................

- Inspection date: ……………….

- Inspection contents:

- Representatives of the facility:

1.....................

2.....................

I/ OPINIONS OF THE INSPECTORATE:

After verifying the documents, considering the reports submitted by the facility, and carrying out a field inspection, the inspectorate hereby makes the following remarks:

A. Strengths:

1. Organizational structure:

2. Training:

3. Workshop

4. Equipment:

5. Sanitation:

6. Verification:

7. Documentation:

8. Complaints and recalls:

9. Internal inspection:

10. Quality control:

11. Warehouses:

B. Shortcomings:

1. Organizational structure:

2. Training:

3. Workshop

4. Equipment:

5. Sanitation:

6. Verification:

7. Documentation:

8. Complaints and recalls:

9. Internal inspection:

10. Quality control:

11. Warehouses:

II/ Conclusion of the inspectorate:

………………………………………………………………………………………………

………………………………………………………………………………………………

………………………………………………………………………………………………

III/ Opinions of the facility

.................................................................................................................................

.................................................................................................................................

.................................................................................................................................

This record is made into 03 copies 01 copy is kept by the facility, 02 copies is kept by Department of Animal Health

Bài viết liên quan