DECISION OF THE MINISTER OF HEALTH

REGARDING THE IMPLEMENTATION AND APPLICATION OF THE PRINCIPLES AND STANDARDS

"GOOD MANUFACTURING PRACTICE FOR MEDICINES" AS RECOMMENDED BY THE WORLD HEALTH ORGANIZATION

THE MINISTER OF HEALTH

Pursuant to the Law on Protecting People's Health dated 11/7/1989;

Pursuant to the Ordinance on Product Quality dated 24/12/1999;

Pursuant to Decision No. 1613/BYT-QD dated 15/5/2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decision No. 108/2002/QĐ-TTg dated 15/8/2002 of the Prime Minister approving the "Strategy for the Development of the Pharmaceutical Industry to 2010";

Pursuant to Decision No. 108/2002/QĐ-TTg dated August 15, 2002 of the Prime Minister approving the "Strategy for the Development of the Pharmaceutical Industry to 2010";

                                                         DECISION:

Article 1. IMPLEMENT THE PRINCIPLES AND STANDARDS "GOOD MANUFACTURING PRACTICE FOR MEDICINES" AS RECOMMENDED BY THE WORLD HEALTH ORGANIZATION at all pharmaceutical manufacturing facilities in Vietnam.

Article 2. ISSUE WITH THIS DECISION GUIDELINES ON THE IMPLEMENTATION OF "GOOD MANUFACTURING PRACTICE FOR MEDICINES" AS RECOMMENDED BY THE WORLD HEALTH ORGANIZATION.

Article 3. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.

Article 4. The Director of the Drug Administration of Vietnam shall be responsible for organizing the implementation of the principles and standards "GOOD MANUFACTURING PRACTICE FOR MEDICINES" as recommended by the World Health Organization.

Article 5. The Heads of the Office of the Ministry of Health, the Inspectorate of the Ministry of Health, the Director of the Drug Administration of Vietnam, the Heads of units under the Ministry, the Directors of Provincial Health Services, and the Health Departments shall be responsible for enforcing this Decision.

   GUIDELINES FOR IMPLEMENTATION AND ENFORCEMENT

GUIDELINES FOR IMPLEMENTING

"GOOD MANUFACTURING PRACTICE FOR MEDICINES"

AS RECOMMENDED BY

THE WORLD HEALTH ORGANIZATION

I. GENERAL PROVISIONS:

1. Purpose:

(ISSUED TOGETHER WITH Decision No. 3886/2004/QĐ-BYT

dated November 3, 2004 of the Minister of Health)

On September 9, 1996, the Minister of Health signed Decision No. 1516/BYT-QĐ on the implementation and application of the principles and standards "GOOD MANUFACTURING PRACTICE FOR MEDICINES" of the Association of Southeast Asian Nations (ASEAN-GMP) at all new drug manufacturing facilities. After eight years of implementation, many pharmaceutical manufacturing facilities have met the ASEAN-GMP standards. The Vietnamese pharmaceutical industry has shown significant changes, with enterprises meeting the ASEAN-GMP standards producing many quality drugs for users and export, achieving the basic goals of the National Medicines Policy of Vietnam. The ASEAN-GMP principles and standards are fundamentally based on the recommendations of the World Health Organization. However, to move towards a global economy, harmonize international standards on "Good Manufacturing Practice for Medicines," and promote exports and cooperation with other countries, the Minister of Health decides to apply the principles and standards "Good Manufacturing Practice for Medicines" as recommended by the World Health Organization (WHO-GMP).

2. DEFINITIONS AND ABBREVIATIONS: a) Certain terms used in these guidelines are understood as follows:

PHARMACEUTICAL MANUFACTURING FACILITY is a facility operated by individuals or organizations engaged in pharmaceutical business that has the function of manufacturing medicines.

NEW DRUGS are raw materials for drugs or finished products made from chemical substances, biological products, or purified active ingredients from natural sources.

HERBAL MEDICINES

are products derived from animals, plants, and minerals without a defined chemical structure or purified active ingredients.

b) ABBREVIATIONS:

GMP: Good Manufacturing Practices, translated as "Good Manufacturing Practice for Medicines."

3. Subjects of application:

WHO: World Health Organization, translated as World Health Organization.

ASEAN: Association of Southeast Asian Nations, translated as Association of Southeast Asian Nations.

All pharmaceutical manufacturing facilities operating within the territory of Vietnam.

4. DOCUMENTS FOR IMPLEMENTATION:

II. IMPLEMENTATION:

a) Guidelines for implementing the principles and standards of WHO-GMP

b) The latest documents of the World Health Organization on GMP and regulations of the Ministry of Health on GMP.

1. DISSEMINATION, TRAINING, AND EDUCATION:

 a) The Drug Administration of Vietnam shall organize dissemination, training on WHO-GMP, and inspection of WHO-GMP for provincial health services, health departments, and pharmaceutical manufacturing facilities.

b) Pharmaceutical manufacturing facilities shall be responsible for researching, training, and guiding the implementation of WHO-GMP principles and standards for all staff within their units.

2. APPLICATION PROCEDURES FOR INSPECTION:

a) INITIAL APPLICATION FORM FOR INSPECTION

Pharmaceutical manufacturing facilities implementing the principles of "Good Manufacturing Practice for Medicines" shall conduct self-inspection and evaluation to ensure they meet the WHO-GMP standards, prepare an application form for inspection of "Good Manufacturing Practice for Medicines." The application form for inspection includes:

Application Form for Inspection of "Good Manufacturing Practice for Medicines" (Form No. 01/GMP)

Attached Documents:

1. Business registration certificate or enterprise establishment permit

2. Organizational chart and personnel list of the facility (the organizational chart must clearly show the name, position, and technical qualifications of the staff responsible for each department), work history and experience in the assigned field of the staff responsible for each department (production, quality control, quality assurance, warehouse).

3. Training program and results of "Good Manufacturing Practice for Medicines" training at the unit.

4. Plant layout diagram including overall floor plan; worker route diagram; material, packaging, semi-finished product, finished product route diagram; water treatment system diagram for production; air handling system diagram at the plant; cleanroom classification diagram; pressure differential diagram between rooms and areas; waste treatment system diagram.

5. List of existing equipment in the plant (including production and quality control equipment - Must show the name of the equipment, year of manufacture, country of manufacture, and condition of the equipment).

8. Environmental impact assessment report of the production and business facility, which has been reviewed and evaluated by the state management agency on environmental issues.

9. Self-inspection record of "Good Manufacturing Practice for Medicines" (the self-inspection record must clearly indicate the inspection period, the members of the self-inspection team, the objectives of the inspection, the results of the self-inspection, and recommendations for corrective actions and timelines).

The application dossier for the "Good Manufacturing Practice for Medicines" inspection shall be made in three copies and submitted to the Vietnam National Pharmaceutical Administration at 138A Giang Vo Street, Ba Dinh District, Hanoi City.

b) Application dossier for re-inspection:

Two months before the expiration date of the certificate of "Good Manufacturing Practice for Medicines," the facility must submit the application dossier for re-inspection of "Good Manufacturing Practice for Medicines." The dossier includes:

1. Re-inspection application form for "Good Manufacturing Practice for Medicines" (Form No. 02/GMP)

2. Report on changes made by the facility during the past two years of implementing "Good Manufacturing Practice for Medicines."

3. Report on the facility's activities over the past two years.

4. Report on the rectification of deficiencies noted in the previous inspection report.

5. Summary report on training and education conducted by the facility over the past two years.

6. Report on the most recent self-inspection and evaluation (within the last three months) regarding the implementation of "Good Manufacturing Practice for Medicines."

c) Preparation and reporting when inspected:

Facilities subject to "Good Manufacturing Practice for Medicines" standards must provide reports in the form of diagrams, charts, and concise data on their operational status and the implementation of "Good Manufacturing Practice for Medicines" principles and standards.

During GMP inspections, all activities of the facility must be ongoing.

For facilities applying for initial inspection:

The facility must produce at least three batches of products to assess the production process and related issues on the registered production line. Full documentation of these product batches and relevant supporting documents must be included in the dossier.

3. Inspection and issuance of certificates

a) Standards for inspectors of "Good Manufacturing Practice for Medicines":

Inspectors must have a university degree or higher, specifically a bachelor's degree in pharmacy, chemical engineering, or microbiology, with knowledge and experience in GMP inspections, production, and/or quality control of medicines, and pharmaceutical management. They must be thoroughly familiar with GMP principles and standards, and have received training in GMP and inspection methods.

They must be honest, accurate, and impartial.

They must employ scientific methods, comply with regulations, and possess the ability to quickly identify deficiencies in the facility while also being able to propose convincing measures to help the facility address shortcomings.

They must be in good health and not suffer from communicable diseases.

b) Authority to inspect and issue certificates:

The Vietnam National Pharmaceutical Administration is responsible for receiving, reviewing the application dossiers, forming inspection teams, conducting inspections, and issuing certificates of compliance with "Good Manufacturing Practice for Medicines" standards to facilities that meet GMP requirements.

Reviewing the application dossier for "Good Manufacturing Practice for Medicines" inspection.

Upon receipt of complete application dossiers for "Good Manufacturing Practice for Medicines" inspection from the facility in accordance with this guidance, the Vietnam National Pharmaceutical Administration will review the dossiers. Within sixty days from the date of receipt of valid dossiers, the Vietnam National Pharmaceutical Administration will issue a decision to establish an inspection team.

If the dossier does not fully meet the requirements, the Vietnam National Pharmaceutical Administration will request the facility to supplement the information.

Conducting inspections and handling inspection results:

Inspection:

Composition of the inspection team: Decided by the Vietnam National Pharmaceutical Administration.

Scope of inspection: The inspection team is responsible for inspecting all activities of the medicine manufacturing facility according to GMP-WHO principles and standards and current professional regulations.

The inspection record shall be made in three copies: one copy retained by the facility, two copies retained by the Vietnam National Pharmaceutical Administration. The record must be signed and confirmed by the facility manager and the head of the inspection team. The inspection record must clearly identify deficiencies in the implementation of GMP at the facility.

In cases where the facility disagrees with the inspection team's opinions, all reservations of the facility must be recorded in the record.

Handling inspection results:

For initial inspections:

If the inspected facility meets the GMP-WHO principles and standards, the Vietnam National Pharmaceutical Administration will issue a certificate of compliance with "Good Manufacturing Practice for Medicines." The certificate is valid for two years from the date of issuance.

For facilities that generally meet the GMP-WHO principles and standards but have some deficiencies that do not affect the quality of the medicine and can be corrected within a short time, the inspection team will require the facility to report on corrective actions. Within two months from the date of inspection, the facility must correct the deficiencies and report the results to the Vietnam National Pharmaceutical Administration. The head of the inspection team will compile and report to the Director for consideration and issuance of the "Good Manufacturing Practice for Medicines" certificate to the facility.

For facilities that do not meet the GMP-WHO principles and standards, the facility must take corrective actions. After self-assessment and confirmation of compliance with GMP standards, the facility must resubmit the initial inspection application dossier.

For re-inspections:

Regular GMP-WHO inspections are conducted every two years, except in special cases requested by the facility or the Ministry of Health (Vietnam National Pharmaceutical Administration).

If the facility continues to meet the GMP-WHO principles and standards, the Vietnam National Pharmaceutical Administration will continue to issue the "Good Manufacturing Practice for Medicines" certificate.

During the inspection, if serious violations affecting the quality of a medicinal product or all products are discovered, the head of the inspection team has the authority to prepare a record and report to the Director of the Vietnam National Pharmaceutical Administration for formal action.

III. IMPLEMENTATION PLAN:

1. From the date this Decision takes effect, all medicine manufacturing facilities must implement and apply GMP-WHO principles and standards.

2. New chemical medicine manufacturing facilities must meet GMP-WHO standards before they are allowed to commence production.

3. For pharmaceutical production facilities that are currently constructing pharmaceutical manufacturing plants according to GMP principles and standards, they may still be inspected and issued with ASEAN-GMP or WHO-GMP certificates if the facility's self-inspection and evaluation meet the standards and they register for inspection according to ASEAN-GMP or WHO-GMP principles and standards.

4. For facilities that have already met the ASEAN-GMP standards, the GMP certificate remains valid until its expiration date. Production facilities must register for re-inspection according to WHO-GMP standards.

5. For units that are permitted to produce pharmaceuticals, they must develop plans to organize research and implement the WHO-GMP principles and standards:

a) By the end of 2005, all chemical pharmaceutical production facilities must comply with GMP principles and standards.

b) By the end of 2006, all chemical pharmaceutical production facilities must comply with WHO-GMP principles and standards.

c) By the end of 2010, all enterprises with the function of producing herbal medicines must meet WHO-GMP standards.

During the implementation process, if units or individuals encounter difficulties, they should submit their opinions to the Vietnam National Medicines Administration for consolidation and reporting to the Minister of Health for consideration and resolution.

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Form No. 01/GMP: Application for Inspection of "Good Manufacturing Practice for Pharmaceuticals"

    NAME OF THE MANAGING UNIT           SOCIALIST REPUBLIC OF VIET NAM NAM

             NAME OF THE UNIT                                                                Independence - Freedom - Happiness

                                                       ..., day ..., month ..., year 200...

APPLICATION FOR INSPECTION OF GOOD MANUFACTURING PRACTICE FOR PHARMACEUTICALS

Respected: Vietnam National Medicines Administration

1- Name of the facility:

2- Address:

3 - Telephone: Fax: E-Mail:

Implementing Decision No. .../2004/QD-BYT dated ..., month ..., year 2004 of the Minister of Health on the implementation of the "Good Manufacturing Practice for Pharmaceuticals" principles recommended by the World Health Organization, after conducting self-inspection and evaluation and meeting the "Good Manufacturing Practice for Pharmaceuticals" standards, our facility hereby applies to the Ministry of Health (Vietnam National Medicines Administration) for inspection of WHO-GMP for the pharmaceutical production lines ...

We hereby attach the following related documents with this application:

1. Business Registration Certificate or establishment permit.

2. Organizational structure and personnel list of the facility.

3. Training materials on "Good Manufacturing Practice for Pharmaceuticals".

4. Plant layout diagrams including overall floor plan; worker pathway diagram; raw material, packaging, semi-finished product, finished product pathway diagram; water supply system diagram for production; air supply system diagram for the plant; cleanroom classification diagram; waste treatment diagram.

5. List of existing equipment in the plant.

6. List of products currently produced or planned to be produced.

7. Fire prevention and control acceptance confirmation or report from the competent authority.

8. Environmental protection compliance confirmation from the competent authority.

9. Self-inspection report on "Good Manufacturing Practice for Pharmaceuticals".

Entity representative

(Signature, full name, stamp)

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Form No. 02/GMP: Application for Re-inspection of "Good Manufacturing Practice for Pharmaceuticals"

    NAME OF THE MANAGING UNIT           SOCIALIST REPUBLIC OF VIET NAM NAM

              NAME OF THE UNIT                                                        Independence - Freedom - Happiness

..., day ..., month ..., year 200...

APPLICATION FOR RE-INSPECTION OF GOOD MANUFACTURING PRACTICE FOR PHARMACEUTICALS

Respected: Vietnam National Medicines Administration

1- Name of the facility:

2- Address:

3 - Telephone: Fax: E-Mail:

Implementing Decision No. .../2004/QD-BYT dated ..., month ..., year 2004 of the Minister of Health on the implementation of the "Good Manufacturing Practice for Pharmaceuticals" principles recommended by the World Health Organization, after conducting self-inspection and evaluation and meeting the "Good Manufacturing Practice for Pharmaceuticals" standards, our facility hereby applies to the Ministry of Health (Vietnam National Medicines Administration) for re-inspection of WHO-GMP for the pharmaceutical production lines ...

We hereby attach the following related documents with this application:

1. Changes made by the facility during the past two years of implementing "Good Manufacturing Practice for Pharmaceuticals".

2. Report on rectifying deficiencies from the previous inspection.

3. Summary report on training and education activities conducted by the facility.

4. Summary report on the facility's operations over the past two years.

5. List of existing equipment in the plant.

6.List of products currently being produced.

7.Self-inspection and evaluation report of the facility in the most recent period regarding the implementation of "Good Manufacturing Practice for Pharmaceuticals".

Entity representative

(Signature, full name, stamp)