Circular No. 07/2012/TT-BNNPTNT stipulates procedures for registering, inspecting, and certifying veterinary drug production facilities meeting Good Manufacturing Practice (GMP) standards.

CIRCULAR

Regulations on the registration, inspection, and certification of veterinary drug manufacturing facilities meeting Good Manufacturing Practice (GMP) standards

đạt tiêu chuẩn thực hành tốt sản xuất thuốc (Good Manufacturing Practice - GMP)

_______________________

Pursuant to the Veterinary Law dated April 29, 2004;

Pursuant to Decree No. 33/2005/NĐ-CP dated March 15, 2005 of the Government detailing the implementation of certain provisions of the Animal Health Ordinance;

Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, and organizational structure of the Ministry of Agriculture and Rural Development; Pursuant to Decree No. 75/2009/NĐ-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government;

The Ministry of Agriculture and Rural Development issues this Circular regulating the procedures for registering, inspecting, and certifying veterinary drug manufacturing facilities meeting Good Manufacturing Practice (GMP) standards.

PART I

 GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. This Circular regulates the procedures for registering, inspecting, and certifying veterinary drug manufacturing facilities meeting Good Manufacturing Practice (GMP) standards.

2. This Circular applies to domestic and foreign organizations engaged in the production of veterinary drugs in Vietnam.

Article 2. Interpretation of Terms

The terms used in this Circular shall be understood as follows:

1. GMP is the abbreviation in English for Good Manufacturing Practice – Good Manufacturing Practices, including general principles, regulations, and guidelines on basic conditions for production, applicable to pharmaceutical, cosmetic... manufacturing facilities to ensure product quality and safety.

2. GMP-WHO is the set of Good Manufacturing Practice standards issued by the World Health Organization, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Storage Practice (GSP).

được thế giới ban hành, bao gồm Thực hành tốt sản xuất thuốc (Good Manufacturing Practice - GMP), Thực hành tốt kiểm nghiệm thuốc (Good Laboratory Practice - GLP), Thực hành tốt bảo quản thuốc (Good Store Practice - GSP).

3. GMP-ASEAN is the set of Good Manufacturing Practice standards issued by the Association of Southeast Asian Nations in 1996 for pharmaceutical production.

4. Some abbreviations:

- HVAC (heating-ventilation-air conditioning: heating-ventilation-air conditioning): Air handling system

- AHU (Air Handling Unit): Air handling equipment.

- SOP (Standard Operating Procedure): Standard operating procedure.

Article 3. Event-based Surveillance Monitoring Guide applied to issue GMP certificates

1. Guidelines for implementing GMP-WHO.

2. Guidelines for implementing GMP-ASEAN.

3. The latest documents from the World Health Organization and the Association of Southeast Asian Nations on GMP.

4. Documents stipulated by the Ministry of Agriculture and Rural Development on Good Manufacturing Practices.

Article 4. Implementation timeline for GMP standards

1. Veterinary drug manufacturing facilities must meet GMP standards.

2.Implementation schedule for GMP

a) For production lines of injectable or liquid oral medications: by December 31, 2010. By this deadline, if there is no GMP certificate, products produced will only be allowed to circulate until December 31, 2012.

b) For production lines of oral powder or feed mixing medications: by December 31, 2012. By this deadline, if there is no GMP certificate, products produced will only be allowed to circulate until December 31, 2013.

c) For production lines of injectable powder medications: by December 31, 2012. By this deadline, if there is no GMP certificate, products produced will only be allowed to circulate until December 31, 2014..

d) For vaccine production lines: by December 31/2014. By this deadline, if there is no GMP certificate, products produced will only be allowed to circulate until December 31, 2015..

Article 5. Fees and charges for inspection and issuance of GMP certificates

1. The facility applying for inspection and certification of GMP must submission fees, charges in accordance with regulations currently prescribed by the Ministry of Finance. Fees and charges must be paid directly at the Department of Animal Health or transferred.

2. The facility must pay the review fee when submitting the application for inspection and certification of GMP.

Chapter II

REGISTRATION FOR GMP INSPECTION

Article 6. Forms of Inspection

1. Initial inspection is conducted at a veterinary drug manufacturing facility that is registering for the first time to be inspected and certified for GMP, or a facility with a revoked GMP certificate wishing to re-certify.

2. Surprise inspections are carried out when signs of violation of GMP principles are detected at a veterinary drug manufacturing facility or upon request of state management agencies at various levels.

3. Re-inspection of GMP is conducted when the GMP certificate expires.

Article 7. Inspection Authority and Issuance of Certificates

1. The Animal Health Department shall be responsible for receiving, reviewing applications for GMP inspection, forming inspection teams, conducting inspections, and issuing certificates of compliance with GMP standards to facilities that meet the requirements after inspection.

2. Composition of the GMP Inspection Team ||| The Director of the Animal Health Department decides on the composition of the team, which includes experienced experts in GMP both within and outside the industry. Cục Thú y quyết định, gồm các chuyên gia có kinh nghiệm về GMP trong và ngoài ngành.

Article 8. Initial GMP Inspection

1. Veterinary drug production facilities implementing GMP must produce at least three batches of products on each registered production line to self-inspect and evaluate according to GMP principles and standards, and prepare an application for registration of "Good Manufacturing Practices" inspection.

Production facilities submit three sets of documents to the Animal Health Department. The documents include:

a) a) Application for GMP Inspection (Annex 01); b) Business Registration Certificate or establishment permit of the enterprise;

c) Organizational structure and personnel chart of the facility: The organizational structure must clearly show the names, positions, and technical qualifications of staff responsible for various departments; their work history and experience in the assigned field, including production, quality control, quality assurance, warehouse, and mechanical-electrical departments;

c) d) Plant layout and design diagrams (production workshop, laboratory, warehouse), including: Overall floor plan; Worker pathway diagram; Raw material, packaging, semi-finished product, finished product pathway diagram; Water treatment and supply system diagram; HVAC system distribution diagram (AHU); Cleanroom classification diagram; Pressure, temperature, humidity differential diagram between rooms and areas; Waste treatment system diagram; Fire prevention and extinguishing system;

d) e) Training program, training materials, and evaluation results of GMP training at the facility;

f) List of existing equipment in the plant, including production, storage, and quality testing equipment (equipment name, serial number, year of manufacture, country of manufacture, and condition of the equipment);

e) g) List of Standard Operating Procedures (SOPs);

g) h) List of products currently being produced or planned to be produced (including drug name, active ingredient, dosage form, packaging specifications);

i) Confirmation certificate or fire prevention and extinguishing acceptance report issued by the competent authority where the production facility is located;

i) Environmental impact assessment report approved by the state management agency for the environment;

k) j) Self-inspection report on GMP, including: date of inspection; composition of the inspection team; inspection objectives; inspection process; evaluation of inspection results: clearly stating the requirements met and remaining issues; recommendations: clearly stating the plans, measures, and specific timeframes to address remaining issues;

l) New establishments applying for GMP inspection must also submit the professional practice certificate of the facility owner or technical manager and the professional practice certificate of the quality control department head.

m) GMP inspection application

2. File must have a cover page and table of contents, arranged in accordance with the table of contents, with clear separation between sections. Section separations must be numbered for easy reference and confirmed by the applicant at the beginning of each section in the entire application. Types of business registration certificates, professional practice certificates, confirmation certificates or fire prevention and extinguishing acceptance reports, environmental impact assessment reports submitted with the application may be provided in one of the following forms:. - Original;

- Legal copy (certified copy);

- Photocopy, while presenting the original for verification if submitted directly.

- Bản sao chụp (photocopy) đồng thời phải xuất trình bản chính để kiểm tra trong trường hợp nộp trực tiếp.

3. Time limit for resolution

Within thirty working days from the date of receipt of the application, the Animal Health Department will review the application and request modifications or supplements if the application does not meet the requirements. Animal Health Bureau thẩm định hồ sơ, yêu cầu sửa đổi, bổ sung nếu hồ sơ không đạt yêu cầu.

Within sixty days from the date of receipt of complete and valid applications, the Director of the Animal Health Department will issue a decision to establish the GMP Inspection Team and notify the schedule for inspection to the facility and proceed with the inspection.

Within ten working days from the end of the inspection, the Animal Health Department will issue a GMP certificate to the facility that meets the requirements or respond in writing if the facility does not meet the requirements.

4. Inspection Process

a) Facilities undergoing GMP inspection must report on their operations and implementation of GMP principles and standards through diagrams, charts, and concise data.

b) During the GMP inspection, all activities must be ongoing.

c) Inspection content: all activities of the veterinary drug production facility according to GMP principles and standards, as per the facility's application and current professional regulations.

Inspection content is recorded in the Inspection Report: one copy retained by the facility, two copies retained

by the Animal Health Department (Annex 2).

In cases where the facility disagrees with the inspection team's opinions, these opinions are noted and recorded in the report.

5. Xử lý kết quả kiểm tra

5. Handling of Inspection Results

a) Based on the Inspection Report, the inspection team leader recommends the issuance of a GMP certificate by the Director to facilities meeting GMP principles and standards.

b) For facilities basically meeting GMP principles and standards but having some issues that can be resolved in a short period, the inspection team requires the facility to rectify and repair. Within two months from the inspection date, the facility must rectify and repair and submit a written report to the Animal Health Department. The team leader reviews and recommends the issuance of a GMP certificate by the Director of the Animal Health Department to the facility that meets the requirements.

Article 9. Re-inspection of GMP

1. Three months before the GMP certificate expires, the production facility must prepare and submit three sets ofre-inspection registration dossier for GMP to the Veterinary Department. The dossier includes:

a) Application form for re-inspection of GMP (Annex 01);

b) Changes made by the facility during the two years of implementing GMP;

c) Report on addressing issues identified in the previous inspection;

d) Report on training and education conducted by the facility;

d) Report on the facility's operations over the past two years;

e) List of current equipment at the factory;

g) List of products currently being manufactured;

h)||| h) List of products currently being produced or planned to be produced (including drug name, active ingredient, dosage form, packaging specifications);

i) Environmental impact assessment report approved by the state management agency for the environment;

k) j) Self-inspection report on GMP, including: date of inspection; composition of the inspection team; inspection objectives; inspection process; evaluation of inspection results: clearly stating the requirements met and remaining issues; recommendations: clearly stating the plans, measures, and specific timeframes to address remaining issues;

l) Minutes of the most recent self-inspection and evaluation conducted by the facility within the last three months regarding the implementation of GMP.

2. The format of the dossier, time limit for processing, inspection procedures, and handling of inspection results shall be carried out in accordance with Clause 2, 3, 4, and 5 of Article 8 of this Circular.

Article 10. Validity of the Certificate

The GMP certificate is valid for two years from the date of issuance.

Article 11. Revocation of the GMP Certificate

1. The entity that has been issued a GMP certificate is responsible for maintaining the production conditions of the factory in compliance with GMP principles and standards throughout the validity period of the GMP certificate.

2. The GMP certificate will be revoked in the following cases:

a) An unscheduled inspection reveals that the facility has violated GMP principles, significantly affecting the quality of pharmaceutical products.

b) The facility refuses inspection when requested by the competent authority more than twice.

3. The decision to revoke the GMP certificate shall be made in two copies: one copy sent to the entity whose certificate is revoked and one retained by the inspecting agency.

Chapter III

IMPLEMENTATION PROVISIONS

Article 12. Effectiveness

This Circular takes effect forty-five days from the date of signature.

Article 13. Implementation

The Veterinary Department is responsible for disseminating and guiding organizations to register for GMP inspections to implement this Circular.

During implementation, if there are any difficulties, organizations should report them to the Ministry of Agriculture and Rural Development (Veterinary Department) for timely adjustment and supplementation./.