The DECISION to enact regulations of veterinary hygiene conditions for production facilities, veterinary medicine business _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ the MINISTER of AGRICULTURE and RURAL DEVELOPMENT, pursuant to Decree No. 73/CP dated November 1, 1995 by the Government mandate the functions, duties, powers and organization of the Ministry of agriculture and rural development;

Pursuant to "provisions on enforcement of the Ordinance on veterinary medicine"; "Veterinary management regulations" attached to Decree No. 93/CP 27/11/1993 of the Government;

At the suggestion of the Director of the Department of animal health, decision: article 1. Attached to this decision a regulated veterinary hygiene conditions for production facilities, veterinary business consists of 40 articles and addendum 2.

Article 2. This decision takes effect after 3 months from the date of signing, the previous provisions contrary to this regulation are repealed.

Article 3. The Chief of the Department, Director of animal health, Director of science and technology and product quality, the heads of the relevant agencies and organizations, individuals and foreigners have manufacturing operations, business veterinary on Vietnamese territory is responsible for the implementation of this decision.

REGULATION of veterinary hygiene conditions for production facilities, veterinary medicine business _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (attached to decision No 47/1999/QD-BNN-COMPANY on 5/3/1999 of the Minister of agriculture and rural development), chapter I.

GENERAL PROVISIONS article 1. In this regulation the terms below are interpreted as follows: 1. veterinary hygiene conditions: include veterinary hygiene requirements for location of establishments, factories, shops, dealers, equipment, tools, the production and business activities of veterinary drugs;

2. veterinary materials: including the substances directly involved in formula composition of the product, whether or not there are active, transformative or not had variations in the production process;

3. veterinary medicinal products: the product was over one or several stages of production, also must continue through one or several stages of production again became the product;

4. Finished products veterinary drugs: is a form of any drug that has passed all the stages of production (including packaging) manufacturing process;

5. Material: is the type of packaging used for packaging, storage and transportation; drug labels used in all stages of production, the type of materials used in the process of producing veterinary products.

6. Label the material is allowed to use: Is the label of the base paste on the packaging containing the material (besides the original manufacturer's label) after a test vote of confirmation of quality standards.

7. products: Label is the label used for each stage of production before the product was perfected, tagged on the standby switch to packaging the following phases according to the production process.

8. Sterilization: Is a stage of the manufacture of veterinary medicines aims to make every sterile instruments, vehicles, environment used for the production of veterinary drugs.

Article 2. This regulation applies to: 1. veterinary drugs production base consists of:-pharmaceutical production facilities (including san split);

-Drug production base in eastern medicine for use in veterinary medicine;

-Production of veterinary vaccines;

-Production facilities the probiotics used in veterinary medicine.

2. Business establishments veterinary drugs include:-stores, dealers buy and sell veterinary drugs; business establishments, smoking materials, veterinary drugs.

-The base register preserved veterinary;

-Basis shipping registration veterinary.

Chapter II.

Veterinary HYGIENE CONDITIONS for veterinary medicine PRODUCTION FACILITIES a. LOCATION of article 3. Veterinary medicine production base to ensure the following conditions: 1. no pollution from the external environment;

2. Not bad influence to the surrounding environment.

3. The difference with residential, public buildings, hospitals, veterinary clinics, animal disease diagnostic facility.

Article 4. Pharmaceutical production facilities, used in eastern medicine to have the main areas, as follows: 1. Warehouse of raw materials, finished products;

2. production Areas include: a/sterile processing areas;

b/production preparation areas;

c/area coordinator;

d/area improving the product;

d/product test area before;

e/toilet area.

Article 5. The basis of the production of vaccines and biological products used in veterinary medicine to have the main area, as stipulated in article 4 of this regulation; In addition to the following areas: a-captive area and process laboratory animals b-areas hold the same microorganisms to produce.

B. the WATER USED in the BASE article 6. The water used in the facility to ensure the following requirements: 1. Met the test of water under TCVN 5942-1995 and TCVN 5944-1995 attached to decision No. 229/QD-TĐC dated 25 March 1995 of the Ministry of science, technology and the environment.

2. in the production lines of sterile water products to ensure the provisions of paragraph 1, this; There must have been water treatment system design, construction techniques, maintenance and operating well, ensuring a quality water supply to meet the norms of physics, chemistry, micro-organisms as defined in Appendix 2 of this regulation.

Article 7. Distilled water: distilled water used in the manufacture of veterinary medicines in accordance with the industry standards of distilled water: 10 BC 243-99 issued under decision No. 112/SCIENCE and TECHNOLOGY/AGRICULTURE QD on 28 November 1995 the Minister of agriculture and rural development.

C. WORKSHOP TOOLS AND EQUIPMENT.

Article 8. Veterinary medicine production factory must ensure the following requirements: 1. Adequate conditions of sanitation, hygiene, ease detoxification; Dust-proof, reduce, and the intrusion of insects and other animals; Each area must have an area consistent with the requirement of production facilities; easy to perform the manipulation techniques in production, facilitate the supervision.

2. Designed and deployed accordingly to avoid confusion or contamination between raw materials, products.

In the case of establishments manufacturing products from the highly toxic materials or easily cause reactions and some antibiotic in the B factory, the Lactam is a private repository area layout and layout separate production.

3. Each area must ensure veterinary hygiene norms as defined in annex 1 of this regulation.

Article 9. Equipment and instruments used in manufacture must ensure the following requirements: 1. Suitable, convenient operation, easy for cleaning and maintenance, ensure environmental hygiene, not to influence the surrounding areas.

2. The surface of contact with the tool, equipment, materials, products, material and finished products must be made of an inert material, not influencing level of purity, of the raw materials, supplies, reduce the quality of the drug.

3. mechanical devices, devices that use electric power, thermal energy, the pressure equipment must be prescribed in writing about the adjustment mode, checking, maintenance, operation to ensure safety and ensure product quality.

Article 10. The repository must ensure the following requirements: 1. Must have separate areas containing raw materials; material, material; finished products; Have a private external repositories for storing the types of solvents and raw materials easily cause fire, explosion and where to store the raw materials, semi-finished products, finished products were removed.

2. About building structure: a/the walls and ceiling are made of durable material, sure;

b/floor are made of a hard material, not rift, not infuse or stagnant water.

3. Equipment, vehicles, tools, chemicals warehouse detoxification must match the stored raw materials, supplies, materials, finished products, requirements for weight and allocated.


4. Must have enough equipment of check veterinary hygiene standards of preservation, have regular record mode the specifications.

Article 11. The area treated, sterilized must ensure the following rules: 1. Must have a separate place for the types of work:-Place the toilet handle mechanics, chemistry for pipe shell, shell vases, bottles, buttons, tools, equipment, processing workers;

-Where the drying, cleaning sterilization ampul, bottles, tools, means of work meet at the request of each stage of production;

-Place the handle cancel the unqualified materials put into the production, semi-finished or finished products not expired or standard user.

2. About building structure: made under the provisions of clause 2, article 10, this regulation. Private floor where sanitary processing mechanics must have 1.5 degree slope toward the trench and high friction to avoid slippery.

3. Must have the equipment, tools, chemicals consistent with mechanical process, chemistry and handle sterilized.

4. Must be specified in writing on the mode of handling hygiene before and after production for the ampule, bottles, jars, boxes or other types of packaging container, glass or metal tool used in manufacturing, corks, bottles, buttons, map labor protection.

Article 12. Production preparation areas must ensure the following requirements: 1. About building structure: a/production line for vaccines, Biologicals, drugs injection, antibiotics: in addition to the provisions in paragraph 2, article 10, this regulation, the wall, ceiling and floor have to smooth, easy hygiene and detoxification.

b/for the production line of powder processing and distribution, taking the form of nuggets, pellets, aqueous; the drug use; yeast micro-organisms is made under the provisions of clause 2, article 10, this regulation.

2. Layout adjacent to the area of production of products waiting for the Pack to avoid product contamination or pollution substances from this product to other products in the production base has many different production lines.

3. There is enough equipment and instruments necessary to receive raw materials, supplies, materials prepared for the production of products packaged under the pending production process.

Article 13. The area of production of products waiting for package (hereinafter referred to as the manufacturing sector) must ensure the following requirements: 1. About building structures are made according to the provisions in point a, paragraph 1, article 12, to this regulation. Particularly for manufacturing vaccines, biological preparations, antibiotics, injections, wall and ceiling have to have high gloss. Confluence between the foot of the wall and the floor surface must be ensured, not jail corner form dust, rubbish, easy hygiene, detoxification.

2. Must have the means to replace the sterile sterile outfit before working in sterile areas. Not deployed sink and drainage trench openings in the sterile area.

3. Must have enough equipment, chemicals and specialized materials match product manufacturing process. With own production line of vaccines, biological preparations, antibiotics, injections, chemicals, equipment must be sterilized to ensure sterile conditions, in the production process.

Article 14. Product finishing area must ensure the following requirements: 1. Be positioned adjacent to the production area to the reception waiting product packaging was convenient.

2. About building structures are made according to the provisions of clause 2, article 10, this regulation.

3. Must have sufficient equipment and instruments consistent with the packing, labelling, shipping the product to the warehouse of finished products. Must have books recorded the number, status of each batch of finished products.

Article 15. Product test area before, stored, preserved the form must follow the following rules: 1. the test area before product must be arranged into two separate places: a/product inspection:-About building structures are made according to the provisions in point a , Paragraph 1, article 12, to this regulation.

-Must have enough equipment, tools, chemicals, the environment consistent with the process of checking the final product before;

b/where laboratory animals serves for checking the quality of products to ensure the request as the laboratory animal breeding specified in article 17 of this regulation.

In case of insufficient basis on conditions, have to send samples to the testing centre veterinary State to test.

2. The retention, preservation of samples and paperwork related to the form as specified in article 20, regulation of quality control of veterinary drugs attached to decision No 191/1998/QD-BNN-COMPANY on 1/12/1998 the Minister of agriculture and rural development.

Article 16. The area keep the same microorganisms for the production must ensure the following requirements: 1. About building structures are made according to the provisions in point a, paragraph 1, article 12, to this regulation.

2. is there sufficient equipment and instruments used for the infusion, implanted, check and keep the same microorganism breeding process, keeping each of the varieties of microorganisms.

Article 17. Farming area processed and animal experiments must ensure the following rules: 1. Must have a separate location, fenced with decorative go separately, there are chemicals for disinfection, detoxification and all media types on or off.

2. Must have a system of separate breeding kennel, cage match each type of animal experiments.

3. the animals were injected serves to transfer production or test products must be farmed in the area separated from other areas; the doors have pit, barrel targets.

4. Must have food container for animal experiments fenced grids against rats, insects invade; breeding tools repository; old appliances, chemical warehouses seem born detoxification.

5. Must have the appropriate means to move animals from breeding zone to other zones, ensures safe, don't waste scattered on the move.

6. Must have the correct animal processing place under the rules of the facility that are approved by the competent authority.

Article 18. Sanitation sector must ensure the following requirements: 1. Must have a reasonable layout, the doors cannot be passed directly to the manufacturing sector.

2. The background must be made of smooth sliding material, with appropriate, easy slope sewer, easy hygiene.

3. Have sufficient sanitary equipment needed; There is enough room, swooping chemicals, items needed for personal hygiene and the area.

4. ventilation equipment, deodorizing.

Article 19. Collection systems and waste management must ensure the following rules: 1. The system of waste water must be consistent with the design of factories, production scale, ensuring collectors from every source of escape targets, causing no pollution to the factory area and out of the manufacturing sector according to the standards specified in annex 2 of this regulation.

2. Each area in the base must have proper waste containers, easy to transport. Waste in the production area must be disinfected before moving to detoxification centres outside the region of production.

3. Must have adequate tools, means of disinfection, chemicals, waste, waste detoxification ensures safe.

D. PACKING, packing article 20. The type of packaging in direct contact with raw materials, semi-finished products, finished products must ensure the following rules: 1. Make sure the physics, chemistry, mechanical structure consistent with each type of raw material, finished goods, does not alter the composition, active, avoid the impact from outside as the light , humidity, microorganisms during storage.

2. glass packaging in addition to the provisions in clause 1, it must guarantee, durability in handling, transportation, storage. Be the last processing using distilled water were examined and preserved not re-infect microbiology before put into use.


Article 21. Preservation, packaging and transport to ensure the following requirements: 1. Must make, durable, cushioned inserts between the inner packing unit, consistent with the loading, transport.

2. Must have the necessary information about preservation, transportation.

Article 22. The label used in the production process, preserve, transport: 1. drug Labels and trademarks of veterinary medicine must follow the regulations on drug labels and trademarks of veterinary drugs attached to decision No 116 NN-COMPANY/QD on 29/11/1995 of the Minister of agriculture and rural development.

2. In addition to the provisions in clause 1, the thing, the label used in the production process must ensure the following rules: a/the label material is allowed to use must be signed by the person in charge of production engineering base. Not be used when the raw material has not been tested quality.

b/label products must have enough content and must be signed by the person in charge of production engineering.

c/finished product Labels and label preservation, transportation not be other changes to drug labels sign up circulation was browsing.

Sync the PRESERVATION Article 23. Warehouses for preservation of raw material, materials, accessories, finished products must ensure the following requirements: 1. the appropriate repository capacity production scale;

2. The device must ensure the specification preserves such as humidity, temperature, luminosity, ventilation level and must have a capacity of warehouse structure fit, require maintenance.

3. The arrangement in the repository must be the written rules of the facility. Must have periodic examination modes, detection and timely handling of problems in the process of preservation.

4. Perform regular recording mode indicators veterinary hygiene in preservation.

E. TRANSPORT article 24. The transportation in the manufacturing sector must ensure the following requirements: 1. The road transport in the area produced must be reasonable layout, ensure safe transport of raw materials, materials, accessories, products, waste, does not impair the operation of any area.

2. Means of transport must be enclosed, compact, clean, not to scattered on road transport, does not cause adverse impact to the raw materials, materials, accessories, finished goods during transportation.

Article 25. The transportation of the product from production to consumption must ensure the following requirements: 1. To avoid bad impacts from outside reducing the quality of the product during shipping.

2. Must have means suit cold preservation preservation requirements to transport văc-please and probiotics.

G. DECONTAMINATION, DETOXIFICATION.

Article 26. The sanitation, decontamination, detoxification for factory must be specified in writing on the following issues: 1. The schedule of hygiene, disinfection, periodic detoxification for each area.

2. The means, instruments, chemicals and methods used.

3. test mode of the base under the veterinary hygiene standards are prescribed.

Article 27. The use of the equipment, instruments, costumes (hereinafter referred to as widgets) in the sterile area must ensure the following rules: 1. Item must be sterilized before use in the sterile area and must be placed in the basket, tray or other containers are labeled to identify sterilized. When put into the sterile area must be put through extra door door inside, a wing outside the borders of transport corridors.

2. the written instructions on the way of packing the widgets provide sterile processing of materials for packing sterilized, brought about the methods and equipment for sterilization should use for various items types, 3. Take measures to avoid infection was born before and during use.

H. HYGIENE Article 28. People working in manufacturing establishments veterinary drugs must ensure the following requirements: 1. Must be healthy, be periodic health check and qualified under the provisions of the Ministry of health.

2. professional training, personal hygiene, industrial hygiene in the production of veterinary drugs.

3. Must have enough equipment, costume work consistent with the nature of the work of each area. Equipment, costumes for people working in sterile areas are sealed, made of material less release dust; change and sterilized after each production shift.

Article 29. People working in manufacturing establishments veterinary drugs must make good the following regulations: 1. personal hygiene before, during and after work.

2. do not bring personal toiletries, into the workplace. Do not wear the clock, use cosmetics while working in sterile areas; Don't wear a costume to work in other areas.

3. Only allowed food, drink, smoking at the place specified in the break between ca. After the break before continuing the work to make the rules of personal hygiene. Do not make the break between shifts for the production has high requirements of industrial hygiene.

I. LABOR ROOM HYGIENE article 30. Veterinary medicine production base should ensure the following requirements: 1. Must have equipped labor rooms to suit each individual assignment.

2. Must have written regulations on issuing mode, use of equipment, work attire.

3. Must have fire fighting equipment, deodorizing, ventilation, dust extraction with suitable capacity; Safety equipment available for the use of the thermal equipment, electrical, mechanical, pneumatic.

4. Must have written rules about labor rooms, have active measures and means to prevent and resolve quickly problems are likely to occur.

Chapter III.

Veterinary HYGIENE BUSINESS ESTABLISHMENTS, PRESERVE, transport, veterinary medicine article 31. Shops, dealers buy and sell veterinary drugs, veterinary materials must ensure the following rules: 1. Must have a fixed address, there are clear signs stating the name of the business or the business name, trading code is granted;

2. Must have sufficient facilities required to display, sales;

3. Must have enough kinds of books import export tracking; Business registration listing table, the table listed on the formulary are allowed to do business.

There are separate the tracking window appears, enter the material for poison, toxic products.

4. Must have warehouses full of equipment, means of preserving fit requires preservation of the drugs, drug materials business is allowed.

5. To store private material poison, toxic products and must have a sticker on the outside as defined in Articles 6, 7, 9 of the regulations on drug labels and trademarks of veterinary drugs attached to decision 116 NN-COMPANY/QD on 29/11/1995 of the Minister of agriculture and rural development.

6. Not allowed sold drugs, veterinary materials along with other goods.

Article 32. The basis of the preservation of veterinary medicine must ensure the following rules: 1. Must have a fixed address, convenient for import goods, not bad influence to the surrounding area.

2. every container must be consistent with the type of goods that need preservation.

3. Must have adequate equipment and facilities required to ensure a quality fit required preservation. Shelf, cargo racks have to be the way the background of at least 20 cm, 20 cm away to ensure ventilation, easy hygiene objectives. As for the facilities to preserve vaccines, biological preparations or microorganisms used in veterinary medicine to have the specialized equipment with suitable capacity containers and stored.

Article 33. The base transport veterinary must ensure the following rules: 1. Must have a fixed address, make sure the contact and information easily.

2. Transport of drugs, veterinary materials must be stored with each type of the product on all the way to shipping.

Chapter IV.


THE AUTHORITY REVIEWS THE ELIGIBILITY CERTIFICATION OF PRODUCTION, BUSINESS AND VETERINARY MEDICINE; For EVALUATION, testing of veterinary HYGIENE CONDITIONS Article 34. The jurisdiction test, evaluation of veterinary sanitation and certification of eligible production, veterinary medicine business is regulated as follows: 1. The veterinary Bureau is responsible for the evaluation of veterinary hygiene conditions of the premises registered veterinary activities, the basis of the register of business activities preservation, transport, veterinary centrally, the basis of foreign investment, joint ventures with foreign countries, representative offices of foreign organizations.

2. Veterinary Bureau is responsible for the evaluation of veterinary hygiene conditions for organizations and individuals to register business activities, preservation, transportation of the veterinary department in the local management.

Article 35. The registration procedure for the evaluation of veterinary hygiene conditions: manufacturing, trading, storing, use the same microorganism used in veterinary medicine as defined in article 2 of this regulation, when registration must sign the evaluation included with registration documents according to the regulations on the procedure of registration of production business, laboratory testing, veterinary, like microorganisms used in veterinary medicine issued the attached decision 194 NN-COMPANY dated 31 March 1994 of the Minister of agriculture and food industry (now the Ministry of agriculture and rural development) and the other legal texts concerned.

Article 36. The order of evaluation of veterinary hygiene conditions were defined as follows: 1. When a valid registration records, veterinary authorities according to the provisions of article 34 of this regulation, to conduct the evaluation according to the regulations.

2. Report on the evaluation was created shortly after the end of the appraisal and must have enough signatures of mission and home base. The minutes are made in 2 copies to save the base and assessment agency.

3. Report on the evaluation, certificate of veterinary hygiene norms is the legal base for certification of eligible activities.

2. The certificate of eligible activities is provided for registered establishments when there are eligible under the rules. When the evaluation conclusions are not eligible, individual organizations can recommend appraisal after repair, fix the content not yet satisfactory in the times appraisal before.

3. qualified certificate worth 1 year from date of issue. 1 month before the expiration of the registration procedure to do.

Article 37. Basis please appraise veterinary hygiene conditions have the responsibility and authority as follows: 1. responsibility: a/file registration in accordance with the provisions of the law.

b/construction rules of the facility, specific provisions in each area, each stitch work and checking the work performed according to the regulations.

c/pay, expenses as prescribed by the Ministry of finance, Ministry of agriculture and rural development.

2. Powers: Are complaints when it does not agree with the conclusions in the report on the evaluation or the evaluation, please leave the conclusion of veterinary sanitation indicators.

Chapter V.

Veterinary HYGIENE INSPECTION Article 38. Checking veterinary sanitation facility are performed in the following cases: 1. Evaluation of veterinary hygiene conditions for the registration of the new facility.

2. Evaluation of veterinary hygiene conditions again when required to base reissuing the certificate when the old paper expired or would operate again after some time.

3. Check out irregularly at the request of the competent authority.

4. Inspections at the request of the competent authority when there is a dispute, complaint, report on the implementation of sanitary and veterinary regulations.

Article 39. Sanitary inspection agency animal health is responsible for: 1. The layout of officials preparing the media at the request of the evaluation work.

2. Set the minutes of sample analysis and answer results accurate, timely regulation and ensure safety in the implementation process.

3. The head of the unit responsible for veterinary hygiene inspection are responsible before the law about the unit's test results.

Chapter VI.

The TERMS of the IMPLEMENTATION of Article 40. Responsibility: the Director of animal health in the scope of the functions, duties, their powers are responsible for guiding the implementation of this regulation.

In the process of implementing this provision, if any problems should immediately report the Ministry of agriculture and rural development (animal health) reviewed, resolved.