(a) The factory director must have a secondary school education or the corresponding technical title, familiar with veterinary drug production technology, and engaged in the production of veterinary drugs for more than three years.
(ii) the head of the veterinary drug production and quality inspection departments, must be a pharmacist in charge, engineer, veterinarian or above technical title of professional and technical personnel, and engaged in the production or inspection of veterinary drugs for more than three years.
Quality inspection personnel should be the profession of technical personnel above the secondary school or specialized training and qualified inspectors.
(c) veterinary drug production workers should have a junior high school education, quality inspection workers should have a high school education, and after professional and technical training, skilled in production and inspection operations.
Electricians, boiler workers and other auxiliary workers must be qualified by the labor department. Article V Veterinary drug manufacturers of factories, plants, must have the following basic conditions:
(a) there must be a hygienic and clean environment, fire safety facilities and three waste disposal facilities, production areas and living areas should be separated. Biological products plant should also have facilities to prevent the dispersal of poison. Non-veterinary drug factory also produces veterinary drugs, there must be a separate veterinary drug production area or production workshop.
(ii) the layout of the plant and workshop should be in line with the requirements of the production process, there should be enough space and place to neatly and reasonably placed equipment and stacking materials. Different varieties and different specifications of drugs and various processes shall not be operated in the same room. The main production workshop should have dustproof, anti-bacteria, anti-mosquito insects and other facilities, especially the refining, drying, packaging workshop and preparation workshop of APIs.
(C) the production of sterile preparations, the workshop should have air purification devices, there should be a sterile buffer room and closed isolation of the studio. Production of proprietary Chinese medicine should be drying field. The production of biological products should also have aseptic operation room, animal breeding houses, incineration facilities, sewage treatment equipment.
(d) Veterinary medicine factory should have with the production of veterinary medicine appropriate storage facilities. Raw materials, auxiliary materials, intermediates, semi-finished products, finished products, as well as substandard products must be stored separately and clearly marked. Special requirements for the storage of drugs to have the appropriate conditions. Cold storage of biological products shall not be stored in the cold storage of other items at the same time. Dangerous goods and highly toxic drugs should be stored separately according to regulations. Flammable and explosive substances should be stored away from the plant. Article VI according to the production of varieties, veterinary drug manufacturers should have the following basic pharmaceutical production equipment:
(a) aqueous injections: there should be redistilled water, stainless steel dispensing tanks, film filters, cut round machine, washing machine, ampoule dryer, autoclave sterilization cabinets, printing and packaging machines, air filtration and ventilation equipment.
(2) powder injection: there should be bottle washing machine, bottle drying equipment, metering dispenser, cap rolling machine.
(C) tablets: there should be crusher, mixer, granulator, tablet press, drying equipment and air dust removal equipment.
(D) feed drug additives: there should be a crusher, electric sieve, dryer, double screw mixer, measuring and loading machine. Distribution of easy oxidation failure of drugs should be vacuum nitrogen packaging machine.
(E) Chinese medicine bulk: there should be crusher, mixer, electric sieve, herbal washing pool and dust, drying equipment.
(F) biological products: there should be bottle transfer machine, culture tanks, filters, lyophilizers, incubators, capping and packaging machines, autoclave cabinets, ovens, refrigeration equipment and so on. Article VII of veterinary drug manufacturers of quality inspection organizations must comply with the "Rules for the Implementation of Veterinary Drug Administration Regulations," the provisions of Article VII. Quality inspection organization directly under the leadership of the factory director.
Quality inspection organization should have a strict sampling, inspection records and inspection reports of the audit and issuance system, to develop quality inspection procedures. Article VIII of veterinary drug manufacturers should establish the necessary systems: raw and auxiliary materials inspection and use system, semi-finished product inspection system, new product approval system, major quality accidents, safety systems, health systems, personal hygiene and medical examination system, etc.; should have the production process as well as operating procedures. Article 9 The raw materials, auxiliary materials, containers, packaging materials and packaging, labeling, products used by veterinary drug manufacturers shall comply with the "Regulations on the Administration of Veterinary Drugs" and "Regulations on the Administration of Veterinary Drugs Implementation Rules". Chapter III Veterinary Drug Business Enterprises shall have the basic regulations Article 10 The personnel of the veterinary drug business enterprises must comply with the "Regulations on the Administration of Veterinary Drugs Implementing Rules," the provisions of Article XVI. Article 11 Veterinary drug business enterprises must have a business room, storehouse, credit racks, credits, counters, etc., appropriate to their business operations, and are not allowed to store drugs in the open air. Article 12 The business premises and storehouse shall be clean and sanitary, and have fire safety facilities. The stacking, storing and displaying of medicines shall be neat and tidy. Article 13 The storage and keeping place of veterinary drugs must meet the requirements of physical and chemical properties of all kinds of drugs. There should be anti-pollution, anti-insect, anti-rodent, dust, moisture, mildew and other facilities. Need to avoid light, low-temperature storage of drugs, there should be special equipment. Special management of drugs should be implemented in accordance with relevant regulations.