In order to strengthen the management of veterinary drug production quality, the "Veterinary Drug Production Quality Management Practices" was reviewed and approved by the executive meeting of the Ministry of Agriculture on March 19, 2002. Let me introduce to you the relevant regulations on the veterinary drug production quality management regulations. Information, I hope it will be helpful to you. Measures for the Quality Management of Veterinary Drug Production

Chapter 1 General Provisions

Article 1 This specification is formulated in accordance with the "Regulations on the Administration of Veterinary Drugs".

Article 2: This specification is the basic guideline for veterinary drug production and quality management. It is applicable to the entire process of veterinary drug preparation production and the key processes that affect the quality of finished products in the production of raw materials.

Chapter 2 Organizations and Personnel

Article 3 Veterinary drug manufacturing enterprises should establish production and quality management institutions. The responsibilities of various institutions and personnel should be clear and equipped with a certain number of personnel related to veterinary drugs. Management and technical personnel with professional knowledge and production experience that are suitable for production.

Article 4 The person in charge of veterinary drug production management and quality management of a veterinary drug production enterprise should have a college degree or above in pharmaceuticals or related majors, and have experience in veterinary drug production and quality management.

Article 5 The person in charge of the veterinary drug production management department and the person in charge of the quality management department should have a college degree or above in veterinary medicine, pharmaceuticals and related majors, have practical experience in veterinary drug production and quality management, and have the ability to control veterinary drugs. Make correct judgments and handle practical problems in production and quality management.

The head of the veterinary drug production management department and the head of the quality management department should be full-time personnel and may not hold concurrent posts for each other.

Article 6 Personnel directly engaged in veterinary drug production operations and quality inspection should have a high school education or above, basic theoretical knowledge and practical operation skills. Personnel engaged in production auxiliary work should have a junior high school education or above.

Article 7: Veterinary drug manufacturing enterprises should formulate personnel training plans and train various personnel engaged in veterinary drug production in accordance with the requirements of this specification. Only those who pass the assessment can take up their posts.

Veterinary drug production operators and quality inspection personnel who are engaged in high biological activity, high toxicity, strong pollution, high allergenicity, and those related to human and animal diseases or who have special requirements should undergo corresponding professional qualifications. Technical training.

Article 8: Quality inspection personnel should be trained by the provincial veterinary drug supervision institute and hold a certificate after passing the assessment. The appointment and change of the person in charge of quality inspection shall be reported to the provincial veterinary drug supervision office for record.

Chapter 3 Plants and Facilities

Article 9 Veterinary drug manufacturing enterprises must have a clean production environment, and their air, site, and water quality should meet production requirements. There should be no pollution sources that affect the quality of veterinary drug products around the factory; the ground, roads and transportation in the factory should not cause pollution to the production of veterinary drugs; the overall layout of the production, warehousing, administration, living and auxiliary areas should be reasonable and should not interfere with each other.

Article 10: Factory buildings should be reasonably laid out according to the production process and the required air cleanliness level. Production operations within the same factory building and between adjacent factory buildings must not interfere with each other. Factory design, construction and layout should meet the following requirements:

1. The layout of the production area should comply with the process flow and reduce detours and round-trips in the production process;

2. High cleanliness level The room should be located close to the location where the least number of people arrive and there is less interference. Rooms with the same cleanliness level should be relatively concentrated.

The interconnections between different rooms in the clean room (area) should meet the needs of variety and technology, and measures to prevent cross-contamination should be taken when necessary;

3. Clean room (area) and non-clean room (area) ) should be equipped with facilities to prevent pollution such as buffer rooms, airlocks or air showers;

4. Access doors for personnel and materials in clean workshops should be set up separately, and material transfer routes should be shortened as much as possible;

5. The entrances and exits of materials and finished products should be separated;

6. Personnel and materials entering the clean factory must have their own purification rooms and facilities. The settings and requirements of the purification rooms should be Compatible with the cleanliness level of the production area;

7. Only materials related to the operation are allowed to be placed in the operation area, and necessary process equipment is set up. Areas used for production and storage must not be used as non-area areas. Passage for staff;

8. Elevators should not be located in clean areas. If they do need to be installed, a buffer room should be set up in front of the elevator.

Article 11 Factories and storage areas should have facilities to prevent insects, rodents and other animals from entering.

Article 12: The factory building should be convenient for cleaning work. The floors, walls, ceilings and other internal surfaces of non-clean room (area) factories should be smooth, clean, stain-free, and easy to clean. The inner surface of the clean room (area) should be flat and smooth, impact-resistant, without cracks, with tight interfaces, without particles falling off, and can withstand cleaning and disinfection. The junction between the wall and the ground should be arc-shaped or other measures should be taken, and the ground should be flat. Smooth, seamless, wear-resistant, corrosion-resistant, impact-resistant, easy to dust and clean.

Article 13 According to needs, the factory building should be divided into production areas and storage areas, with an area and space suitable for the production scale, to facilitate production operations and placement of equipment, and to store materials, intermediate products, and products to be inspected. and finished products, and should minimize errors and cross-contamination.

Article 14 According to the requirements of veterinary drug production technology, the air cleanliness level of the weighing room and material preparation room set up in the clean room (area) should be consistent with the requirements of the production conditions, and there should be dust capture and Facilities to prevent cross-contamination.

Article 15: Materials must be cleaned before entering the clean room (area), and a room for clearing the outer packaging of materials must be set up at the material entrance. Materials required for aseptic production should be transferred through the transfer window or buffer room after sterile treatment.

Article 16: When designing and installing various pipes, lamps, air vents and other public facilities in the clean room (area), consideration should be given to avoiding parts that are difficult to clean during use.

Article 17: Sufficient lighting should be provided in the clean room (area) according to production requirements. The minimum illumination in the main studio shall not be less than 150 lux, and local lighting may be set up in production areas with special requirements for illumination. The factory building should have emergency lighting facilities. The minimum illumination in other areas of the factory shall not be less than 100 lux.

Article 18 The air entering the clean room (area) must be purified, and the air cleanliness level must be divided according to the production process requirements. The number of microorganisms and dust particles in the air in the clean room (area) should be monitored regularly, and the monitoring results should be recorded and archived.

Article 19 The windows and ceiling of the clean room (area) and the connections between the pipes, air outlets, lamps and walls or ceilings entering the room should be sealed. The static pressure difference between adjacent clean rooms (areas) with different air cleanliness levels should be greater than 5 Pa. The static pressure difference between the clean room (area) and the non-clean room (area) should be greater than 10 Pa. The static pressure difference between the clean room (area) and the outdoor atmosphere (including areas directly connected to the outdoors) should be greater than 12 Pa, and there should be a device to indicate the pressure difference or a monitoring and alarm system. For clean room workshops of biological products, the absolute value of the static pressure difference specified above should be determined according to process requirements.

Article 20 The temperature and relative humidity of the clean room (area) should be consistent with the requirements of the veterinary drug production process. When there are no special requirements, the temperature should be controlled at 18-26℃ and the relative humidity should be controlled at 30-65.

Article 21: Pools and floor drains installed in clean rooms (areas) must not contaminate veterinary drugs.

Article 22: Measures should be taken to prevent cross-contamination when people and materials enter and exit between clean rooms (areas) with different air cleanliness levels.

Article 23: The production of highly allergic veterinary drugs such as penicillins and lactam structural drugs should use relatively independent workshops, facilities and independent air purification systems. The packaging room should maintain a relatively negative pressure and exhaust gases. The exhaust gas to the outdoors should be purified and meet the requirements, and the exhaust outlet should be far away from the air inlet of other air purification systems. If it is necessary to use the discontinued workshop to repackage other products, it must be cleaned, no residues must be left, and other products can only be produced after passing the test.

Article 24: Biological products should be produced separately according to different types and properties of microorganisms. Virulent strains and attenuated strains, strains for production and non-production

strains for strains, cells for production and cells for non-production, live vaccines and inactivated vaccines, pre-inactivation and sterilization The production and operation areas and storage equipment after survival, before detoxification and after detoxification should be strictly separated.

Article 25 The production operation area of ??traditional Chinese medicine preparations should be separated from the production operations such as pre-processing, extraction, concentration of traditional Chinese medicine materials, and the washing or processing of animal organs and tissues. The pre-processing operations of Chinese herbal medicines should have good ventilation, smoke exhaust and dust removal facilities.

Article 26 The design, installation and maintenance of process water treatment and supporting facilities should ensure that the set quality standards and needs are met, and the manufacturing procedures, storage methods, and procedures for process water should be formulated. Quality standards, inspection operating procedures and facility cleaning procedures, etc.

Article 27 Dry air, compressed air and inert gases that are in direct contact with veterinary drugs should be purified, and their cleanliness level should be the same as that in the clean room (area).

Article 28: The buildings in storage areas should meet the requirements of moisture-proof and fire-proofing, and the storage area should be suitable for the classification and orderly storage of materials and products. To-be-inspected, qualified and unqualified materials and products should be stored in separate warehouses or strictly stacked and stored separately, and should be clearly marked for easy identification.

Materials or products that have special requirements for temperature and humidity should be stored under storage conditions that can ensure their stability.

Flammable and explosive dangerous goods and waste products should be stored in special or isolated warehouses. Toxic drugs, narcotic drugs, and psychotropic drugs should be stored according to regulations.

The storage area should have fire protection distances and traffic passages that comply with regulations.

Article 29: Storage areas should be kept clean and dry. Lighting, ventilation and other facilities as well as temperature and humidity control should meet storage requirements and be monitored regularly.

The storage area can be equipped with a raw material sampling or weighing room, and the air cleanliness level of the environment should be consistent with the production requirements. If sampling is not done in the sampling room, measures should be taken to prevent contamination and cross-contamination during sampling.

Article 30 The quality management department should set up inspection, traditional Chinese medicine specimens, sample observation and other types of laboratories as needed. It can control the cleanliness, temperature and humidity of the laboratory as needed and coordinate with the production of veterinary drugs. differentiate. Biological testing, microbial limit testing and biological product testing should be carried out in separate rooms for strong and weak toxicity.

Article 31 Instruments and equipment that have special environmental requirements should be placed in a special instrument room and have facilities to prevent the influence of external factors.

Article 32: The experimental animal room should be strictly separated from other areas, and its design and construction should comply with relevant national regulations. The production of veterinary biological products must be equipped with animal rooms for production and testing. To produce other veterinary drug products that require animal testing, veterinary drug manufacturers can set up experimental animal rooms or entrust other units to conduct relevant animal experiments. The experimental animal rooms of the entrusted experimental units must have corresponding conditions and qualifications and comply with regulations. Require.

Chapter 4 Equipment

Article 33 Veterinary drug manufacturing enterprises must have production and inspection equipment suitable for the products they produce, and their performance and main technical parameters should be able to ensure production and product quality control needs.

Article 34: The design, selection and installation of equipment should meet production requirements, be easy to clean, disinfect or sterilize, facilitate production operation and repair and maintenance, and be able to prevent errors and reduce pollution.

When the installation of production equipment needs to span two areas with different cleanliness levels, sealed partition devices should be used.

Article 35: The surface of equipment in direct contact with veterinary drugs should be smooth, flat, easy to clean or disinfect, corrosion-resistant, and should not undergo chemical changes with or adsorb veterinary drugs. Lubricants, coolants, etc. used in equipment must not cause contamination of veterinary drugs or containers.

Article 36 The main fixed pipes connected to the equipment should be marked with the name and flow direction of the materials in the pipes.

Article 37 The preparation, storage and distribution system of purified water and water for injection should be able to prevent the growth and contamination of microorganisms. Materials used for storage tanks and delivery pipelines should be non-toxic and corrosion-resistant. The design and installation of pipelines should avoid dead ends and blind pipes. Storage tanks and pipelines should have specified cleaning and sterilization cycles. The vent of the water for injection storage tank should be installed with a hydrophobic sterilizing filter that does not shed fibers. Water for injection can be stored with insulation above 80℃, insulation cycle above 65℃ or storage below 4℃.

Article 38 The scope of application and precision of instruments, meters, measuring instruments, scales, etc. used for production and inspection should comply with the requirements of production and inspection, have obvious qualification marks, and be inspected regularly. Verification by the legal metrology department.

Article 39: Production equipment should have obvious status signs and should be repaired, maintained and verified regularly. Equipment installation, repair, and maintenance operations must not affect the quality of the product. Unqualified equipment should be moved out of the production area and should be clearly marked before moving out.

Article 40: Production and inspection equipment and instruments should have procedures for use, repair, cleaning and maintenance, regular inspection, cleaning, maintenance and repair, and should be managed and recorded by dedicated personnel.

Article 41 Equipment files should be established for major production and inspection equipment, instruments, and weighing instruments, including: manufacturer, model, specifications, technical parameters, instructions, equipment drawings, spare parts list, and installation location and construction drawings, as well as inspection and maintenance content and records, verification records, accident records, etc.

Chapter 5 Materials

Article 42 A management system should be formulated for the purchase, storage, distribution and use of materials used in the production of veterinary drugs.

Article 43 The materials required for the production of veterinary drugs shall comply with veterinary drug standards, drug standards, packaging material standards, veterinary biological products regulations or other relevant standards, and shall not have any adverse impact on the quality of veterinary drugs. Imported veterinary drugs should have an inspection report from the port veterinary drug supervision office.

Article 44: Traditional Chinese medicinal materials used in the production of veterinary drugs should meet quality standards, and their origins should remain relatively stable. The outer packaging of Chinese medicinal materials should be marked with the product name, place of origin, source, processing date, and be accompanied by a quality certificate.

Article 45: Materials used in the production of veterinary drugs should be purchased from legal or legal units that meet prescribed conditions and stored in storage in accordance with regulations.

Article 46: Materials to be inspected, qualified, and unqualified should be strictly managed, with obvious signs that are easy to identify and measures to prevent confusion, and a material flow account card should be established. Unqualified materials should be stored in a special area and disposed of in a timely manner in accordance with relevant regulations.

Article 47 Materials, intermediate products and finished products that have special requirements for temperature, humidity or other conditions should be stored according to prescribed conditions. Solid and liquid raw materials should be stored separately; volatile materials should be careful to avoid contaminating other materials; pure medicinal materials after processing and processing should be used in clean containers or packaging and strictly separated from unprocessed and processed medicinal materials; expensive and toxic medicinal materials etc. should be stored in special counters.

Article 48 The acceptance, storage, custody, use and destruction of veterinary narcotics, psychotropic drugs, toxic drugs (including medicinal materials), flammable, explosive and other dangerous goods shall strictly comply with relevant national regulations. regulations. The acceptance, storage, custody, use and destruction of bacterial and viral strains should comply with national regulations on the storage of veterinary microbial strains.

Article 49 Materials should be stored according to the specified use period. If the use period is not specified, the storage shall generally not exceed three years and shall be re-inspected after the expiration. If there are special circumstances during the storage period, re-inspection should be carried out in time.

Article 50: The labels and instructions for use of veterinary drugs shall be consistent with the content, style and text approved by the animal husbandry and veterinary administrative department. Label content includes: veterinary mark, name of veterinary drug (common name, trade name), active ingredients and their content, specifications, functions and uses, usage and dosage, approval number, production batch number, validity period, withdrawal period, name and address of the manufacturer wait.

The product instructions should include veterinary labels, veterinary drug names, main ingredients, properties, pharmacological effects, uses, usage and dosage, adverse reactions, precautions, withdrawal period, validity period, storage, production batch number, Manufacturer's name, etc.

If necessary, the label and product instructions can be printed on product labels, packaging boxes, and bags at the same time.

Labels and instructions for use should be printed, distributed, and used after being proofread by the enterprise’s quality management department.

Article 51 The labels and instructions for use of veterinary drugs should be kept and used by designated personnel and meet the following requirements:

1. Labels and instructions for use should be based on the variety and specification. There are special counters or special warehouses for storage, which are inspected, kept, issued, and collected by dedicated personnel. They are distributed according to batch packaging instructions and collected according to actual needs;

2. Labels must be counted and distributed, and the recipient must check and Signature, the sum of the used number, damaged number and remaining number should be consistent with the used number. Damaged or remaining labels and packaging materials with batch numbers printed on them should be counted and destroyed by a dedicated person;

3. Issuance and use of labels , Destroy due records.

Chapter 6 Hygiene

Article 52 Veterinary drug manufacturing enterprises should take sanitary measures to prevent pollution, formulate various sanitary management systems for the environment, processes, factories, personnel, etc., and Responsible for this by a dedicated person.

Article 53 Veterinary drug production workshops, processes, and positions should formulate cleaning operating procedures for workshops, equipment, pipelines, containers, etc. according to the requirements of production and air cleanliness levels. The content should include: cleaning methods, Procedures, intervals, detergents or disinfectants used, cleaning methods and storage locations of cleaning tools, etc.

Article 54: Smoking and non-production items and personal debris are not allowed to be stored in the production area, and waste from production should be disposed of in a timely manner.

Article 55 The settings and sanitary environment of changing rooms, bathrooms and toilets shall not have any adverse impact on the clean room (area).

Article 56 The material selection, style and wearing method of work clothes should be consistent with the requirements of production operations and air cleanliness levels. Work clothes in clean rooms (areas) of different levels should be clearly marked and must not be mixed. .

The texture of clean work clothes should be smooth, not generate static electricity, and not shed fibers and particulate matter. Sterile work clothes must cover all hair, beard and feet, and can block human body shedding to the greatest extent.

Work clothes used at different air cleanliness levels should be cleaned and arranged separately, and disinfected or sterilized if necessary. Additional particulate matter should not be introduced into work clothes during washing and sterilization. A cleaning system should be developed for work clothes and the cleaning cycle should be determined. Work clothes used in cultivating pathogenic microorganisms or operating areas should be disinfected and washed.

Article 57: The number of personnel in the clean room (area) should be strictly controlled, and entry is limited to production operators and approved personnel in the area.

Article 58 Personnel entering the clean room (area) are not allowed to wear makeup and accessories, and are not allowed to touch veterinary drugs directly with bare hands.

Article 59 Sanitary tools that are free of falling objects, easy to clean and easy to disinfect should be used in the clean room (area). Sanitary tools should be stored in designated places that will not cause contamination to the product, and their use should be limited. area. Clean rooms (areas) should be disinfected regularly, and the disinfectants used must not contaminate equipment, materials and finished products. Disinfectant varieties should be changed regularly to prevent the development of drug-resistant strains.

Article 60: Production personnel should establish health files. Production personnel who are in direct contact with veterinary drugs shall undergo physical examination at least once a year. Patients with infectious diseases, skin diseases and those with wounds on the body surface are not allowed to engage in the production of veterinary drugs with direct contact.

Chapter 7 Verification

Article 61 Veterinary drug production verification shall include plant, facilities and equipment installation confirmation, operation confirmation, performance confirmation, simulated production verification and product verification and instrumentation Calibration of instruments.

Article 62: The production process and key facilities and equipment of the product should be verified according to the verification plan. When the main factors affecting product quality, such as processes, quality control methods, main raw materials and auxiliary materials, main production equipment or main production media, change, and after a certain production cycle, re-verification should be carried out.

Article 63: Verification projects should be proposed based on the verification objects, and working procedures and verification plans should be formulated. The verification work procedures include: proposing verification requirements, establishing a verification organization, completing the approval and organization implementation of the verification plan.

Article 64 The main contents of the verification plan include: verification purpose, requirements, quality standards, conditions required for implementation, test methods, time schedule, etc. After the verification work is completed, a verification report should be written and reviewed and approved by the person in charge of the verification work.

Article 65: The data and analysis content during the verification process should be archived and saved in the form of files. Verification documents should include verification plans, verification reports, evaluations and suggestions, approvers, etc.

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