Quyết định 3886/2004/QĐ-BYT của Bộ Y tế về việc triển khai áp dụng nguyên tắc, tiêu chuẩn Thực hành tốt sản xuất thuốc theo khuyến cáo của Tổ chức y tế thế giới

DECISION

ON APPLICATION OF THE WORLD HEALTH ORGANIZATION'S "GOOD MANUFACTURING PRACTICES" PRINCIPLES AND STANDARDS

THE MINISTER OF HEALTH

Pursuant to the July 11, 1989 Law on Protection of the People's Health;

Pursuant to the December 24, 1999 Ordinance on Goods Quality;

Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Prime Minister's Decision No. 108/2002/QD-TTg of August 15, 2002 approving the pharmaceutical development strategy till 2010;

At the proposal of the director of Vietnam Pharmacy Management Department,

DECIDES:

Article 1.- To organize the application of the World Health Organization (WHO)'s "Good Manufacturing Practices" principles and standards at Vietnam-based medicine-manufacturing establishments.

Article 2.- To promulgate together with this Decision the guidance for application of the WHO’s "Good Manufacturing Practices".

Article 3.- This Decision takes effect 15 days after its publication in the Official Gazette.

Article 4.- The director of Vietnam Pharmacy Management Department shall have to organize the application of the WHO's "Good Manufacturing Practices" principles and standards.

Article 5.- The director of the Office and the chief inspector of the Health Ministry, the director of Vietnam Pharmacy Management Department, the heads of the units, of the Ministry, the directors of the provincial/municipal Health Services, and the branch medical establishments shall have to implement this Decision.

GUIDANCE

ON APPLICATION OF THE WHO'S "GOOD MANUFACTURING PRACTICES"

(Promulgated together with the Health Minister's Decision No. 3886/2004/QD-BYT of November 3, 2004)

I. GENERAL PROVISIONS

1. Purposes:

On September 9, 1996, the Health Minister signed Decision No. 1516/BYT-QD on the application of "Good Manufacturing Practices" principles and standards of the Association of Southeast Asian Nations (GMP-ASEAN) at all western medicine-producing establishments. After 8 years' application, many medicine-producing establishments have satisfied the GMP-ASEAN standards. Vietnam's pharmaceutical industry has seen clear improvements, the enterprises satisfying GMP-ASEAN standards have manufactured quality medicines for users and export, the basic targets of Vietnam's national medicine policy have been attained. GMP-ASEAN principles and standards are substantially based on WHO's recommendations, however, for integration into the global economy, compatibility with international standards on GMP and promotion of the export and cooperation with other countries in the world, the Health Minister hereby decides on the application of WHO's "Good Manufacturing Practices" principles and standard (GMP-WHO).

2. Interpretation of terms, abbreviations:

a/ A number of terms used in this guidance are construed as follows:

- Medicine-producing establishments mean pharmaceuticals business establishments of individuals or organizations that have the function to produce medicines.

- Western medicines mean medicines with raw-materials or finished-product medicines originating from pharmacochemicals, biologicals or from which pure active substances of natural origin.

- Pharmaceutical medicines mean products originating from animals, plants and minerals, whose chemical structures have not yet been determined or from which pure active substances have not yet been prepared.

b/ Abbreviations:

- GMP means Good Manufacturing Practices.

- WHO means the World Health Organization.

- ASEAN means the Association of Southeast Asian Nations.

3. Subjects of application: All medicine-producing establishments operating on the Vietnamese territory.

4. Documents to be applied:

a/ The guidance for application of GMP-WHO principles and standard.

b/ WHO's latest documents on GMP and Vietnam Health Ministry's documents and regulations on GMP.

II. ORGANIZATION OF IMPLEMENTATION

1. Dissemination, training:

a/ Vietnam Pharmacy Management Department shall organize the dissemination and training on GMP-WHO, contents of GMP-WHO examination and inspection for the provincial/municipal Health Services, the branch medical establishments and medicine-producing establishments.

b/ The medicine-producing establishments shall have to study, train and guide the application of GMP-WHO principles and standard for all officials and employees in their respective units.

2. Procedures for inspection registration:

a/ Dossiers of registration for first-time inspection

The medicine-producing establishments that apply GMP principles shall inspect and assess by themselves whether they satisfy GMP-WHO standards, then prepare dossiers of registration for GMP inspection. Such a dossier consists of:

- The written registration for GMP inspection (form No. 01/GMP, not printed herein);

- Enclosed documents:

1. The business registration certificate or the enterprise establishment permit;

2. The plan on the establishment's organization and personnel (which must clearly reflect the names, titles as well as professional and technical qualifications of officials in charge of different sections), working seniority and experiences in the assigned domains of officials in charge of different sections (such as production, quality inspection, quality assurance, warehousing).

3. The unit's GMP training program and assessment of training results.

4. The plan on the factory's location and design, including the general flooring space plan; the plan on workers routes; the plan on itineraries of raw materials, packings, semi-finished products, finished products; the plan on the system of water treatment in service of production; the plan on system of air treatment at the factory; the plan on the factory's levels of cleanliness; the plan on pressure difference between rooms, areas; the plan on the system of waste treatment.

5. The list of the factory's existing equipment (including equipment for medicine production and medicine quality inspection, which must reflect the names of equipment, years of manufacture, countries of manufacture and conditions of equipment).

6. The list of commodities being produced or planned to be produced (clearly stating the forms of preparation).

7. The written certification or pre-acceptance-test record on fire prevention and fighting, issued by the competent authority in the locality where the production establishment is located.

8. The production/business establishment's environmental impact assessment report, which has been evaluated by the agency in charge of State management over environment.

9. The written record on GMP self-inspection (which must clearly reflect the time of inspection, members of inspection team, purposes of inspection, results of inspection, and proposed time and remedial measures).

The dossiers of registration for GMP inspection shall be made in 3 sets and sent to Vietnam Pharmacy Management Department at No. 138A Giang Vo street, Ba Dinh district, Hanoi city.

b/ Dossiers of registration for re-inspection:

Two months before the GMP certificate expires, the establishment must send the dossier of registration for GMP re-inspection. Such a dossier consists of:

1. The written registration for GMP re-inspection (form No. 02/GMP, not printed herein).

2. The report on the establishment's changes in two years' application of GMP.

3. The report on the establishment's operation in the past two years.

4. The report on the settlement of problems mentioned in the previous inspection record.

5. The summarized report on the establishment's training work in the past two years.

6. The establishment's report on latest self-inspection and evaluation (within 3 latest months) on GMP application.

c/ Preparation for and reporting upon inspection:

- The medicine-producing establishments, when being inspected according to the GMP standard, must make reports in diagrams, charts and briefed data on their operation and application of GMP principles and standards.

- When GMP inspection is conducted, the establishment's activities must be underway.

- For establishments registering for first-time inspection:

Establishments must produce at least 3 lots of products for evaluation of production processes and matters related to the chains registered for inspection. Such must be fully reflected in the dossiers of product lots and relevant dossiers and documents.

3. Inspection and certificate granting

a/ Criteria for GMP-inspecting officials:

- Having university or higher degree, being university-degree pharmacists, chemical or micro-biological engineers, having knowledge and experiences in GMP inspection, having experiences in production and/or inspection of medicine quality and pharmacy management; having grasped GMP principles and standards, having been trained in GMP and GMP inspection methods.

- Being honest, accurate and objective.

- Having scientific working methods, observing regulations, being able to rapidly detect establishments' errors, and at the same time suggest convincing measures to help establishments address their shortcomings.

- Being physically fit, having got no contagious diseases.

b/ Competence to conduct inspection and grant certificates:

Vietnam Pharmacy Management Department shall have to receive and evaluate the dossiers of registration for inspection, set up inspection teams, conduct inspection, then grant certificates of satisfaction of GMP standard to the qualified establishments.

- Evaluation of the dossiers of registration for GMP inspection:

After receiving the establishments' complete dossiers of registration for GMP inspection as prescribed in this guidance, Vietnam Pharmacy Management Department shall evaluate the dossiers. Within 60 days after receiving the complete and valid dossiers, Vietnam Pharmacy Management Department shall decide to set up inspection teams.

If the dossiers fail to fully satisfy the requirements, Vietnam Pharmacy Management Department shall request in writing the establishments to supplement the dossiers.

- Inspection and handling of inspection results:

+ Inspection:

* The composition of inspection teams shall be decided by Vietnam Pharmacy Management Department.

* Inspection contents: The inspection teams shall have to inspect all activities of the medicine-producing establishments according to GMP-WHO principles and standards as well as current regulations on professional requirements.

* An inspection record shall be made in 3 copies, 1 of them shall be kept at the establishment and 2 others at Vietnam Pharmacy Management Department. The record must be signed and certified by the establishment's manager and the inspection team's head. The record must clearly state problems in GMP application at the establishment.

In cases where the establishment disagrees with the inspection team’s opinions, the record must clearly state all reservations of the establishment.

+ Handling of inspection results:

* For establishments being inspected for the first time:

· If the inspected establishments satisfy GMP-WHO principles and standards, Vietnam Pharmacy Management Department shall grant certificates of satisfaction of GMP standard. Such certificates shall be valid for two years after their signing.

· For the inspected establishments which basically satisfy GMP-WHO principles and standards, but, there still exist several problems which, however, do not affect the medicine quality and may be addressed in a short period of time, the inspection teams shall request the establishments to report on the remedies. Within two months after being inspected, the establishments must address such problems and make reports on the results of settlement of the problems raised by the inspection teams in the records, sending them to Vietnam Pharmacy Management Department. The inspection teams' heads shall sum up and report thereon to the director for consideration and granting of GMP certificates to the establishments.

· For establishments which have not yet satisfied GMP-WHO principles and standards, they must address the problems. After conducting self-inspection and assessment of satisfaction of GMP standards, they shall submit registration dossiers as for first-time registration for inspection.

* For re-inspected establishments:

GMP-WHO shall be inspected every two years, except for extraordinary cases as requested by establishments or the Health Ministry (Vietnam Pharmacy Management Department).

· If the establishments still satisfy GMP-WHO principles and standards, Vietnam Pharmacy Management Department shall continue to grant GMP certificates.

· In the course of inspection, if detecting that establishments commit violations, thus seriously affecting the quality of a medicine product or all the products, the inspection teams' heads may make records and report thereon to the director of Vietnam Pharmacy Management Department for official handling decision.

III. IMPLEMENTATION PLAN

1. As from the effective date of this Decision, all medicine-producing establishments must apply GMP-WHO principles and standards.

2. Newly built western medicine-producing establishments must satisfy GMP-WHO standards before being allowed to produce medicines.

3. Medicine-producing establishments, which are building medicine-producing factories according to GMP principles and standards, shall still be inspected and granted GMP-ASEAN or GMP-WHO certificates if they conduct self-inspection and assessment of satisfaction, and register for inspection according to GMP-ASEAN or GMP-WHO principles and standards.

4. For establishments which have satisfied GMP-ASEAN standards, GMP certificates shall be valid until they cease to be effective. The production establishments must register for re-inspection according to GMP-WHO standard.

5. For the units which have been permitted to produce medicines, they must devise plans on study and application of GMP-WHO principles and standards:

a/ By the end of 2005, all western medicine-producing establishments must satisfy GMP principles and standards.

b/ By the end of 2006, all western medicine-producing establishments must satisfy GMP-WHO principles and standards.

c/ By the end of 2010, all enterprises functioning to produce pharmaceutical medicines must satisfy GMP-WHO standards.

In the course of implementation, if meeting with any difficulties or problems, units and organizations should report them to Vietnam Pharmacy Management Department for summing up and reporting to the Health Minister for consideration and settlement.