Decision No. 46/1999/QĐ-BNN/TY Issuing the Regulations on Veterinary Sanitary Conditions for Production and Business Units of Veterinary Drugs

Pursuant to …;

Issuing the Regulations on veterinary hygiene conditions for production and business establishments of animal health drugs.

 Production and business establishments of animal health drugs

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THE MINISTER OF AGRICULTURE AND RURAL DEVELOPMENT

Pursuant to the Government Decree No. 73/CP dated November 1, 1995, stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development;

Pursuant to the "Regulations on the Implementation of the Animal Health Ordinance" and the "Regulation on the Management of Animal Health Drugs" issued together with the Government Decree No. 93/CP dated November 27, 1993;

Issued herewith is the Model Records and Decisions for Administrative Sanctions in the Field of Veterinary Medicine.,

Pursuant to …;:

Article 1The Regulations on veterinary hygiene conditions for production and business establishments of animal health drugs, consisting of 40 articles and two appendices, are hereby promulgated together with this Decision.

Article 2. This Decision shall take effect three months from the date of signing, and all previous regulations contrary to these Regulations shall be abolished.

Article 3. The Heads of the Ministry's Office, the Director of the Department of Animal Health, the Director of the Department of Science, Technology and Product Quality, the Heads of related agencies, and domestic organizations and individuals, as well as foreign individuals engaged in the production and business of animal health drugs within the territory of Vietnam, are responsible for implementing this Decision.

REGULATIONS

Veterinary hygiene conditions for production and business establishments of animal health drugs

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(Issued together with the Decision No. 46/1999/QĐ-BNN-TY dated March 5, 1999 of the Minister of Agriculture and Rural Development)

Chapter I.

GENERAL PROVISIONS

Article 1. In these regulations, the following terms are understood as follows:

1. Veterinary hygiene conditions: Include the requirements for veterinary hygiene concerning the location of the establishment, factory, store, agency, equipment, tools, and personnel involved in the production and business of animal health drugs;

2. Raw materials for animal health drugs: Include substances directly participating in the formula of the product, whether or not they have activity, and whether or not they undergo change during the production process;

3. Semi-finished products of animal health drugs: Are products that have undergone one or more production stages and still need to go through one or more additional production stages before becoming finished products;

4. Finished products of animal health drugs: Is any form of drug that has gone through all production stages (including packaging) according to the approved production process;

5. Materials: Are types of packaging used for packaging, storing, and transporting; labels used at every stage of production; and various materials used in the production process to make animal health drugs.

6. Permitted raw material labels: Are labels affixed by the establishment on the packaging containing raw materials (alongside the original label of the manufacturer) after receiving a test report confirming compliance with quality standards.

7. Semi-finished product labels: Are labels used for each production stage before the product is completed, affixed on packaging awaiting transfer to the next production stage according to the approved production process.

8. Sterilization: Is a production stage of animal health drugs aimed at making all tools, means, and micro-environments used for producing animal health drugs sterile.

Article 2. These Regulations apply to:

1. Production establishments of animal health drugs including:

- Pharmaceutical production establishments (including division);

- Traditional medicine production establishments for animal health;

- Animal vaccine production establishments;

- Other biological preparation production establishments for animal health.

2. Business establishments of animal health drugs including:

- Stores and agencies selling animal health drugs; business establishments dealing in raw materials for animal health drugs.

- Establishments registered for storing animal health drugs;

- Establishments registered for transporting animal health drugs.

Chapter II.

CONDITIONS FOR VETERINARY PHARMACEUTICAL PRODUCTION FACILITIES

 VETERINARY DRUGS

A. LOCATION

Article 3. Veterinary drug production facilities must meet the following conditions:

1. Not to be contaminated from external environments;

2. Not to adversely affect the surrounding environment.

3. To be isolated from residential areas, public buildings, hospitals, veterinary clinics, animal disease diagnostic facilities.

Article 4. Pharmaceutical and traditional veterinary medicine production facilities must have the following main zones:

1. Raw material, auxiliary material, finished product storage area;

2. Production area including:

a/ Sterilization processing area;

b/ Pre-production preparation area;

c/ Compounding area;

d/ Finished product completion area;

đ/ Pre-export product inspection area;

e/ Sanitation area.

Article 5. Vaccine and biological product production facilities for veterinary use must have the main zones as stipulated in Article 4 of this Regulation; Additionally, they must have the following areas:

a - Animal testing holding and processing area

b - Microorganism strain preservation area for production.

B. WATER USED IN THE FACILITY

Article 6. Water used in the facility must meet the following requirements:

1. Meet water quality standards according to TCVN 5942-1995 and TCVN 5944-1995 issued with Decision No. 229/QĐ-TĐC dated March 25, 1995 of the Ministry of Science, Technology, and Environment.

2. In sterile product manufacturing lines, water must comply with Clause 1 of this Article; Additionally, there must be a water treatment system designed, constructed, maintained, and operated properly to ensure the supply of water meeting physical, chemical, and microbiological standards specified in Appendix 2 of this Regulation.

Article 7. Distilled water: Distilled water used in veterinary drug production must comply with the industry standard on distilled water: 10 TCN 243-95 issued pursuant to Decision No.: 112 NN/KHCN/QĐ dated November 28, 1995 of the Minister of Agriculture and Rural Development.

C. FACTORY AND EQUIPMENT, TOOLS.

Article 8. Veterinary drug production factories must meet the following requirements:

1. Adequate environmental hygiene conditions, easy to clean and disinfect; Resistant to dust, pests, and insect and animal intrusion; Each area must have appropriate size for production requirements; Facilitate technical operations and monitoring.

2. Designed and arranged appropriately to avoid cross-contamination or contamination between raw materials and products.

In cases where production involves highly toxic raw materials or those prone to reactions and certain types of B-Lactam antibiotics, the factory must have separate storage areas and separate production areas.

3. Each area must meet veterinary hygiene standards as specified in Appendix 1 of this Regulation.

Article 9. Equipment and tools used in production must meet the following requirements:

1. Suitable, convenient for operation, easy to clean and maintain, ensuring environmental hygiene, not affecting adjacent areas.

2. The surface of equipment and tools in contact with raw materials, auxiliary materials, semi-finished and finished products must be made of inert materials that do not affect the purity and activity of these materials, reducing the quality of drugs.

3. Mechanical equipment, electrical and thermal equipment, pressure equipment must have written regulations regarding adjustment, inspection, maintenance, and operation to ensure labor safety and product quality.

Article 10. Storage areas must meet the following requirements:

1. Must have separate areas for storing raw materials; auxiliary materials, materials; finished products; Separate outdoor storage for solvents and flammable and explosive raw materials, and for storing rejected semi-finished and finished products.

2. Structural construction:

a/ Walls and ceilings must be made of durable materials;

b/ Floors must be made of hard materials, non-cracking, non-water absorbing or retaining.

3. Equipment, means, tools, disinfectants must be suitable for raw material, auxiliary material, material, finished product storage requirements, and for weighing and distribution.

4. Must have sufficient self-inspection equipment for veterinary hygiene storage standards, with regular recording of technical parameters.

Article 11. The processing and sterilization area must comply with the following provisions:

1. Must have separate areas for different tasks:

- Area for mechanical and chemical cleaning of tube shells, bottle shells, bottles, caps, compounding equipment, protective gear;

- Area for drying and sterilizing ampules, bottles, equipment, work tools according to production stage requirements;

- Area for disposing of raw materials not meeting production standards, substandard semi-finished or finished products, or expired products.

2. Structural construction: follow the provisions of Clause 2, Article 10 of this Regulation. The floor in the mechanical cleaning area must have a 1.5-degree slope towards the drainage channel and high friction to prevent slipping.

3. Must have sufficient equipment, tools, chemicals suitable for mechanical and chemical processing and sterilization.

4. Must have written regulations for pre- and post-production sanitation procedures for ampules, bottles, boxes, or packaging containing drugs, glass or metal tools used in production, bottle caps, protective gear.

Article 12. The pre-production preparation area must meet the following requirements:

1. Structural construction:

a/ For vaccine, biological product, injectable drug, antibiotic production lines: in addition to the provisions of Clause 2, Article 10 of this Regulation, walls, ceilings, and floors must also be smooth and easy to clean and disinfect.

b/ For oral powder, granule, tablet, solution drug production lines; topical drugs; microbial enzyme preparations must comply with the provisions of Clause 2, Article 10 of this Regulation.

2. Must be adjacent to the production area for products awaiting packaging to avoid product contamination or cross-contamination between different products in facilities with multiple production lines.

3. Must have sufficient equipment and tools necessary to receive raw materials, auxiliary materials, materials for producing products awaiting packaging according to approved production processes.

Article 13. The production area for products awaiting packaging (hereinafter referred to as the production area) must meet the following requirements:

1. Regarding construction, it shall be carried out in accordance with the provisions of Point a, Clause 1, Article 12 of this Regulation. For vaccine production facilities, biological preparations, antibiotics, and injectable drugs, the walls and ceilings must also have high gloss. The junction between the wall base and the floor must form an obtuse angle to ensure that dust and debris do not accumulate, making cleaning and disinfection easy.

2. There must be sterilization equipment available for changing sterile clothing before working in the sterile area. Open washbasins and drainage channels may not be arranged in the sterile area.

3. There must be sufficient specialized equipment, chemicals, and materials suitable for the production process. For vaccine, biological preparation, antibiotic, and injectable drug production lines, there must be sterilization equipment and chemicals to ensure aseptic conditions during production.

Article 14. The finished product completion area must meet the following requirements:

1. It must be located adjacent to the production area to facilitate the reception of products awaiting packaging.

2. Regarding construction, it shall be carried out in accordance with the provisions of Clause 2, Article 10 of this Regulation.

3. There must be sufficient equipment and tools suitable for packaging, labeling, and transporting products to the finished goods warehouse. Records of quantity and condition of each batch of finished products must be kept.

Article 15. The pre-export product inspection, sample storage, and preservation area must comply with the following regulations:

1. The pre-export product inspection area must be arranged into two separate places including:

a/ Product inspection room:

- Regarding construction, it shall be carried out in accordance with the provisions of Point a, Clause 1, Article 12 of this Regulation.

- There must be sufficient equipment, tools, chemicals, and environments suitable for the final product inspection process before export;

b/ Animal testing facility for quality product testing must meet the requirements for animal testing facilities as stipulated in Article 17 of this Regulation.

In cases where the facility does not meet the above conditions, samples must be sent to the National Veterinary Drug Testing Center for testing.

2. Sample storage, preservation, and related documentation management according to the provisions of Article 20 of the Quality Control Regulations for Veterinary Drugs issued together with Decision No. 191/1998/QĐ-BNN-TY dated December 1, 1998, by the Minister of Agriculture and Rural Development.

Article 16. The microbial strain storage area for production must meet the following requirements:

1. Regarding construction, it shall be carried out in accordance with the provisions of Point a, Clause 1, Article 12 of this Regulation.

2. There must be sufficient equipment and tools to serve the transfer, injection, inspection, and storage of microbial strains according to the procedures for maintaining each type of microbial strain.

Article 17. The animal testing facility and processing area must comply with the following regulations:

1. There must be a separate location with barriers and a dedicated pathway, equipped with disinfectants and sterilizers for people and all types of vehicles entering or exiting.

2. There must be separate cages and enclosures suitable for different types of test animals.

3. Animals that have been injected for production or product testing must be housed in a segregated area from other areas; entry and exit doors must have disinfection pits or containers.

4. There must be a food storage area protected against rodent and insect intrusion, a tool storage area, and a storage area for old tools and sterilizing chemicals.

5. There must be appropriate means to transport animals safely from the housing area to other areas without spilling waste along the way.

6. There must be a designated area for disposing of animal carcasses in accordance with the regulations approved by the competent authority.

Article 18. The sanitation area must meet the following requirements:

1. There must be a reasonable layout, and the entrance must not directly connect to the production area.

2. The floor must be made of non-slip material with an appropriate slope for easy drainage and cleaning.

3. There must be sufficient sanitation equipment; there must be enough soap, chemicals, and necessary items for personal and area sanitation.

4. There must be ventilation and odor removal equipment.

Article 19. The collection and treatment system for waste must comply with the following regulations:

1. The wastewater treatment system must be designed appropriately for the factory and production scale, ensuring the collection of wastewater from all sources, preventing pollution within the factory and outside the production area in accordance with the standards set forth in Appendix 2 of this Regulation.

2. Each area within the facility must have appropriate trash bins for easy transportation. Wastes from the production area must be disinfected before being transferred to centralized locations outside the production area.

3. There must be sufficient tools, means, and chemicals for disinfecting and treating waste and wastewater to ensure safety.

D. PACKAGING MATERIALS AND PACKAGING

Article 20. Packaging materials that come into direct contact with raw materials, semi-finished products, and finished veterinary drugs must comply with the following regulations:

1. They must ensure physical and chemical properties, have a mechanical structure suitable for each type of raw material and finished product, without altering their composition or activity, and protect them from external influences such as light, humidity, and microorganisms throughout the storage period.

2. Glass packaging, in addition to the provisions of Clause 1 of this Article, must also be sturdy and durable for handling, transportation, and storage. It must undergo final processing with distilled water that has been tested and stored to prevent recontamination before use.

Article 21. Packaging materials for storage and transportation must meet the following requirements:

1. They must be sturdy and durable, with cushioning between small packaged units inside, suitable for stacking and transportation.

2. They must contain necessary information for storage and transportation.

Article 22. Labels used during production, storage, and transportation:

1. Drug labels and brand labels of veterinary drugs must comply with the Labeling Regulations for Veterinary Drugs and Brand Labels issued together with Decision No. 116 NN-TY/QĐ dated November 29, 1995, by the Minister of Agriculture and Rural Development.

2. In addition to the provisions of Clause 1 of this Article, labels used during production must also comply with the following regulations:

a/ Raw material labels must bear the signature of the production technical manager of the facility. Raw materials may not be used until they have been quality tested.

b/ The label of semi-finished products must contain all necessary information and must be signed by the person responsible for production technology.

c/ The labels of finished products and storage and transportation labels shall not differ from the registered drug labels that have been approved.

D. STORAGE

Article 23. The storage warehouse for raw materials, materials, auxiliaries, and finished products must meet the following requirements:

1. The warehouse capacity must be appropriate to the scale of production.

2. Equipment must meet technical standards for storage such as humidity, temperature, lighting, ventilation, and must have a capacity suitable for the warehouse structure and storage requirements.

3. The arrangement within the warehouse must be specified in writing by the establishment. There must be regular inspection procedures to promptly identify and address any issues during the storage process.

4. Regularly record hygiene indicators for animal health during storage.

E. TRANSPORTATION

Article 24. Transportation within the production area must meet the following requirements:

1. The transportation routes within the production area must be reasonably arranged to ensure safety when transporting raw materials, materials, auxiliaries, finished products, waste, without affecting any other areas.

2. Transport vehicles must be neat, enclosed, clean, and prevent spillage during transportation, avoiding adverse effects on raw materials, materials, auxiliaries, and finished products during transport.

Article 25. Transportation of finished products from the production facility to the place of consumption must meet the following requirements:

1. Prevent negative external influences that reduce product quality during transportation.

2. Must have refrigeration equipment suitable for the preservation requirements to transport vaccines and biological preparations.

G. DISINFECTING AND DECONTAMINATING.

Article 26. Sanitation, disinfection, and decontamination of production facilities must be regulated in writing regarding the following matters:

1. Scheduled sanitation, disinfection, and decontamination for each area.

2. Equipment, tools, chemicals, and methods of use.

3. Self-inspection procedures by the establishment according to the hygiene indicators for animal health as prescribed.

Article 27. The use of equipment, tools, and attire (hereinafter referred to as items) in sterile areas must comply with the following regulations:

1. Items must be sterilized before being used in sterile areas and must be placed in baskets, trays, or other containers labeled to indicate sterilization. When entering sterile areas, they must pass through a secondary door with one side inside and the other adjacent to the transportation corridor.

2. Written guidelines must specify the packaging method for items to be sterilized, the material used for packaging, and the sterilization methods and equipment required for different types of items.

3. Measures must be taken to prevent re-contamination by microorganisms before and during use.

H. PERSONAL HYGIENE

Article 28. Personnel working in veterinary drug production facilities must meet the following requirements:

1. Must be healthy, undergo regular medical examinations, and meet the standards set by the Ministry of Health.

2. Must be trained in professional skills, personal hygiene, and industrial hygiene in veterinary drug production.

3. Must have appropriate work attire and equipment suitable for the nature of work in each area. Work attire and equipment for personnel in sterile areas must be tight-fitting, made of low-dust materials; they must be changed and sterilized immediately after each production shift.

Article 29. Personnel working in veterinary drug production facilities must comply with the following regulations:

1. Personal hygiene before, during, and after work.

2. Personal belongings and items may not be brought into the workplace. Wearing watches, using cosmetics is prohibited in sterile areas; Work attire may not be worn to other areas.

3. Eating, drinking, and smoking are only allowed at designated locations during breaks. After breaks, before resuming work, personal hygiene regulations must be followed. Breaks are not permitted during production stages requiring high levels of industrial hygiene.

I. OCCUPATIONAL HEALTH PROTECTION

Article 30. Veterinary drug production facilities must meet the following requirements:

1. Must provide individual occupational health protection equipment suitable for assigned tasks.

2. Must have written regulations on the distribution and use of work attire and equipment.

3. Must have fire extinguishing, odor removal, ventilation, dust extraction equipment with appropriate capacity; Safety equipment for users of thermal, electrical, mechanical, and compressed air equipment.

4. Must have written regulations on occupational health protection, including proactive measures and equipment to prevent and quickly resolve potential incidents.

Chapter III.

ANIMAL HEALTH SANITATION FOR VETERINARY DRUG BUSINESS, STORAGE, AND TRANSPORTATION FACILITIES

Article 31. Retail stores and agents selling veterinary drugs and raw materials for veterinary drugs must comply with the following regulations:

1. Must have a fixed address with clear signage indicating the name of the business or enterprise and the business registration number issued.

2. Must have sufficient display and sales equipment.

3. Must maintain records of purchases and sales; Business registration boards, lists of permitted drugs for sale.

Separate records must be kept for the purchase and sale of toxic raw materials and preparations.

4. Must have warehouses with appropriate equipment and facilities to store various types of drugs and raw materials for veterinary drugs as permitted for sale.

5. Must store toxic raw materials and preparations separately and must have labels affixed externally as stipulated in Article 6, 7, and 9 of the Labeling Regulations for Veterinary Drugs and Product Markings issued together with Decision No. 116 NN-TY/QĐ dated November 29, 1995 by the Minister of Agriculture and Rural Development.

6. May not sell veterinary drugs and raw materials for veterinary drugs alongside other goods.

Article 32. Veterinary drug storage facilities must comply with the following regulations:

1. Must have a fixed address convenient for goods import and export, without adversely affecting surrounding areas.

2. Warehouses must be designed appropriately for the type of goods to be stored.

3. Must have sufficient equipment and means to ensure product quality in accordance with storage requirements. Shelves and racks must be at least 20 cm above the floor and at least 20 cm from walls to ensure ventilation and easy sanitation. For facilities storing vaccines, biological products, or microorganisms used in veterinary purposes, specialized equipment suitable for warehouse capacity and storage requirements must be provided.

Article 33. Veterinary drug transportation facilities must comply with the following regulations:

1. Must have a fixed address to ensure easy contact and information exchange.

2. Transportation vehicles and raw materials for veterinary drugs must meet storage requirements for each type of product throughout the transportation route.

Chapter IV.

AUTHORITY TO ISSUE CERTIFICATES OF COMPLIANCE FOR THE PRODUCTION AND DISTRIBUTION OF VETERINARY DRUGS; PROCEDURES FOR APPLICATION FOR SANITARY INSPECTION AND APPROVAL

Article 34The authority to inspect, assess sanitary conditions, and issue certificates of compliance for the production and distribution of veterinary drugs is as follows:

1. The Department of Animal Health shall be responsible for assessing the sanitary conditions of facilities applying for veterinary drug production activities, central-level facilities applying for distribution, storage, and transportation activities, foreign-invested facilities, joint ventures with foreign entities, and representative offices of foreign organizations.

2. The Animal Health Sub-department shall be responsible for assessing the sanitary conditions of organizations and individuals applying for distribution, storage, and transportation activities under local management.

Article 35. Procedures for applying for sanitary condition assessment:

Facilities producing, distributing, storing, and using microorganisms for veterinary purposes as stipulated in Article 2 of this Regulation, when registering their operations, must submit an application form for assessment along with the registration dossier according to the procedures for registering veterinary drug production, distribution, testing, and inspection, and microorganism use for veterinary purposes issued together with Decision No. 194 NN-TY/QD dated March 31, 1994 of the Minister of Agriculture and Rural Development (formerly the Ministry of Agriculture and Food Industry), and other relevant legal documents.

Article 36. The procedure for assessing sanitary conditions is as follows:

1. When the registration dossier is valid, the animal health agency as stipulated in Article 34 of this Regulation will conduct the assessment according to the prescribed regulations.

2. The inspection report must be prepared immediately upon completion of the inspection and must contain signatures of the inspection team and the facility owner. The report is made in two copies for the facility and the inspection agency.

3. The inspection report and certificate of sanitary standards serve as legal grounds for issuing the certificate of compliance for operation.

2. A certificate of compliance for operation will be issued to the registered facility if it meets the required conditions. If the inspection conclusion is that the conditions are not met, the organization or individual may request a re-inspection after rectifying and addressing the deficiencies identified in the previous inspection.

3. The certificate of compliance is valid for one year from the date of issuance. One month before expiration, renewal procedures must be completed.

Article 37. The facility requesting a sanitary condition assessment has the following responsibilities and authorities:

1. Responsibilities:

a/ To prepare the registration dossier in accordance with the provisions of the law.

b/ To establish internal rules of the facility, specific regulations for each area and process, and to monitor compliance with these regulations.

c/ To pay fees and costs as prescribed by the Ministry of Finance and the Ministry of Agriculture and Rural Development.

2. Authorities:

To lodge complaints if they disagree with the conclusions in the inspection report or request a re-evaluation of the sanitary standards.

Chapter V.

SLAUGHTER CONTROL,

Article 38. Sanitary condition inspections of facilities are carried out in the following cases:

1. Assessing sanitary conditions for new facilities applying for operations.

2. Re-assessing sanitary conditions when the facility requests a renewed certificate upon expiration of the old one or wishes to resume operations after a period of inactivity.

3. Conducting surprise inspections at the request of authorized agencies.

4. Conducting evaluations at the request of authorized agencies in case of disputes, complaints, or accusations regarding the implementation of sanitary regulations.

Article 39. The inspection agency has the responsibility to:

1. Assign staff and prepare equipment as required for the inspection.

2. Prepare inspection reports and provide accurate results within the prescribed timeframe while ensuring safety during the process.

3. Heads of units responsible for sanitary inspections must bear legal responsibility for the inspection results of their units.

Chapter VI.

IMPLEMENTING PROVISIONS

Article 40. Responsibilities for Implementation:

The Director of the Department of Animal Health, within the scope of their functions, duties, and powers, is responsible for guiding the implementation of this Regulation.

During the implementation of this Regulation, if there are any difficulties, they must be reported immediately to the Ministry of Agriculture and Rural Development (Department of Animal Health) for consideration and resolution.