Chapter II
REQUIREMENTS FOR MANUFACTURING OF VETERINARY DRUGS
Article 3. General requirements for producers of veterinary drugs
1. Location:
a) Be not contaminated from the outside environment;
b) Do not cause adverse impacts on surrounding environment;
c) Be in distant from residential areas, schools, office buildings, hospitals, medical testing and diagnosis facilities;
d) Be convenient for transport, ensure water and power sources for manufacturing activities.
2. Workshop:
a) The workshop must be built in a strong and firm manner in conformity with the nature and the scale of production, avoiding adverse natural impacts such as weather, flood, moisture and the infiltration of insects or other animals;
b) The workshop must have firm, dry, flat and non-slip foundation which has to bear the compression of machinery during the manufacturing of veterinary drugs;
c) Walls and ceiling must be made of strong and solid materials;
d) The floor must not be cracked, be designed to prevent the water absorbance or stagnation, easy for cleaning and suitable for disinfectants;
dd) Have a strong lighting system;
e) The planning for construction must be suitable and conformable to the nature and the scale of production.
g) Each place in the workshop must meet with the criteria of veterinary hygiene as regulated.
3. Equipment:
a) Machinery and equipment must be arranged and installed in conformity with intended operations; operational manual and maintenance plans should be available. There should be the proper industrial cleaning process to prevent the contamination or cross-contamination between products.
b) Equipment must be available as regulated in the Annex No. 1 enclosed with this Circular.
4. Packages:
a) Primary packages must not harm the quality of veterinary drugs contained inside, and may prevent adverse impacts from the outside such as light, moisture, and microorganisms during the preservation of veterinary drugs.
b) Glass packages must be firm and durable kinds in conformity with the sterilization, transport and preservation.
5. Testing laboratory:
a) Must be isolated from the production area. Places for conducting bio-tests and microbiological tests must be separate from each other.
b) Area of the testing laboratory must be enough for avoiding the cross-contamination and maintaining samples and titrants.
c) Equipment must be available as regulated in the Annex No. 2 herein.
d) The testing laboratory manager must possess an appropriate practice certificate which has been granted by the competent veterinary agency as regulated.
6. Personal hygiene:
Workers in producers of veterinary drugs must meet the following requirements:
a) They must be fit for work as regulated by Ministry of Health; go for periodic check-up once for every year; do not have any open wounds and dermatological diseases;
b) They must be trained in professional skills, personal hygiene and industrial cleaning knowledge during the production of veterinary drugs.
c) Workers in producers of veterinary drugs must comply with regulations on veterinary hygiene in the production area.
7. Labor safety and hygiene:
a) Each worker must be provided with labor safety equipment in conformity with his/her assigned tasks.
b) Written regulations on the issuance and use of working equipment and clothing must be promulgated.
c) Fire equipment, and equipment for deodorization, air ventilation and vacuum must be equipped with suitable capacity. Workers who use heating, electrical, mechanical, or compressed air equipment must be provided with safety equipment.
d) Written regulations on labor protection must be formulated; measures and facilities for preventing and solving problems which may occur must be available.
8. Waste collection and treatment system:
a) The wastewater treatment system must be designed in conformity with the workshop and the scale of production, ensuring that the wastewater from all sources must be treated in the appropriate manner and avoiding the pollution in the workshop and surrounding area.
b) Garbage bins must be placed in all areas in the producer in the appropriate manner which must be easy for transport. The wastewater must be treated in conformity with technical regulations before it can be discharged.
Article 4. Requirements for producers of medicinal products and chemicals used in veterinary medicine
1. Warehouse system:
a) Build warehouses and special areas for storing materials, auxiliary materials, packages and finished products; the producer must build a warehouse in the outside for storing explosive and inflammable solvents and materials, and have special areas for storing discarded materials, semi-finished and finished products.
b) The warehouse’s capacity must be in conformity with the scale of production.
c) Necessary equipment and facilities for ensuring the quality of products must be available and in conformity with preservation requirements. To be specific:
Storage at normal conditions: temperature is from 15 to 30 0C, and the humidity shall not exceed 70%;
Cool storage: temperature is from 8 to 15 0C.
Cold storage: temperature is from 2 to 8 0C.
Freezing storage: temperature is ≤-100C.
d) Prevent the direct light and the contamination from the outside environment;
dd) Products must be arranged on brackets/shelves in a tidy and scientific way. Brackets/shelves must be at least 20 cm far away from the foundation surface, and at least 20 cm far away from the walls; the distance between brackets/shelves or that between items of products must be at least 30 cm for ensuring the ventilation and facilitating the warehousing input or delivery of goods, cleaning and sterilization;
e) The producer must promulgate written regulations on the arrangement and preservation of goods, periodical inspection, discovery and handling of problems which occur during the preservation;
g) Equipment for checking preservation standards and policies on regular recording of technical parameters must be available.
2. Sterilization area:
a) It must have a place for practicing mechanical hygiene and chemical hygiene for primary packages, including ampoule covers, vial covers, bottles, and caps, devices and equipment for preparation, and personal protective equipment. The floor surface where the mechanical hygiene is performed must slope about 1.50 towards the drainage ditch and has the rubbing for preventing slip.
b) Ampoules, vials, bottles, caps, devices and personal protective equipment must be sterilized to meet requirements on each manufacturing step.
c) Equipment, devices and chemicals must be suitable for the sterilization;
d) Written regulations on hygiene and sterilization of primary packages, manufacturing devices and personal protective equipment must be promulgated.
3. Area for weighing and delivering materials:
a) Have a separate room for weighing materials. If a separate room for weighing materials is not available, measures against the cross-contamination between kinds of materials must be prepared.
b) Scales and devices for weighing materials must be available and cleaned after they are used.
4. Area for preparation, mixture and storage of semi-finished products:
a) The walls and ceiling must be shiny; the intersection between the foot of the wall and the floor surface, and that between the wall and the ceiling must be obtuse angles.
b) The production line for injectable veterinary drugs: it must have a pre-sterilization room for dressing sterile lab clothing before entering the sterilization area; the sink and the open drainage ditch are not built in the sterilization area.
All equipment must be sterilized before they are moved to the sterile area. They must be stored in sterile conditions with “sterilized” labels.
Measures against re-contamination before and during using must be available.
c) The production line for veterinary drugs in the form of powder: vacuum devices must be equipped.
d) Equipment, devices and chemicals must be available and suitable for the production process.
dd) It must have special area for storing semi-finished products whose division is not yet carried.
5. Area for finishing products;
a) This area must be arranged next to the area for division of drugs for facilitating the receipt of products for packing.
b) Equipment and devices must be available and suitable for the packing, labeling and transport of products to the warehouse of finished products.
6. The area for storing products which fail to meet quality standards must be arranged separately, are lockable or have a warning sign put up to avoid the confusion with other products.
7. The area for inspection of products before they are released:
a) Equipment, devices, chemical and the environment must be in conformity with the procedures for the final inspection of products before they are released. If the producer fails to meet requirements for carrying out the inspection, it must contract a qualified inspection unit to carry out the inspection of products as regulated.
b) Regulations on storage, preservation and inspection of stored samples must be promulgated.
8. Personal hygiene area and other areas serving the production.
a) Must be arranged in an appropriated way and out of contact with the production area.
b) Have necessary equipment, chemicals and devices for practicing personal hygiene and cleaning such areas.
c) Have air ventilation and deodorization equipment.
Article 5. Requirements for producers of vaccines, bio-preparations and microorganisms
Apart from regulations stated in Article 3 and Article 4 of this Circular, producers of vaccines, bio-preparations and microorganisms must have separate areas for raising animals for experimental purpose and treating tested animals; areas and equipment for keeping breeds of microorganisms to serve the production.
Article 6. Requirements for producers of hormones used in the veterinary medicine:
Apart from regulations stated in Article 3 and Article 4 of this Circular, hormones must be produced in a separate place.
Article 7. Requirements for processing, dividing and packing veterinary drugs
Regulations in Clauses 1, 2, 4, 5, 6, 7, and 8 Article 3; Clauses 1 and 2, Points a, c, d Clause 4; Clauses 5, 6, 7, 8 Article 4 of this Circular shall apply.
Tìm kiếm
Thông tư 51/2009/TT-BNNPTNT (Bản Word)