Guangxi Nanning Taoyuan Veterinary Medicine Factory is planned and constructed strictly in accordance with the requirements of veterinary medicine GMP, and consists of a production part and an auxiliary part. The layout is reasonable, and people and materials are diverted, which is conducive to production operations. The acceptance inspections for this application include: final sterilized small-capacity injection / final sterilized large-capacity non-intravenous injection workshop, non-sterile bulk drug (dextran iron) workshop. The total construction area of ​​the workshop is 1380.84m2, of which the raw material complexing workshop is 267m2, the injection workshop is 747.36m2, and the raw material fine baking workshop is 366.48m2.

       Among them, the pretreatment and external packaging processes of the raw material production workshop are general production areas, and the nanofiltration, spray drying, mixing, and inner packaging are 100,000-level clean areas; the injection workshop has bottles sorting, rough washing, sterilization, and light inspection. Processes such as packaging and packaging are general production areas. Processes such as fine washing, thick blending, and capping are 100,000-level clean production areas. Processes such as thinning, fine filtration, and potting are 10,000-level clean production areas. The production areas of different levels are respectively There are sanitary ware storage room and utensils storage room; there are buffer rooms or air lock rooms between the clean area and non-clean area of ​​each workshop, and between different clean areas. The main function room of the clean area is equipped with a thermo-hygrometer to monitor the temperature and humidity in accordance with process requirements; floor drains and pools in the clean area meet the requirements and will not cause pollution to medicines. The interior of the workshop is divided by sandwich color steel plates, and the interface is connected by arc-shaped electrophoretic aluminum profiles. The surface is smooth, flat, dust-free, easy to clean, disinfection-resistant, corrosion-resistant, and fire-resistant. The floor is terrazzo floor or epoxy resin floor, which has the characteristics of wear resistance, dust resistance, washability, antistatic, temperature resistance, pressure resistance, disinfection resistance and good friction. The workshop has a good sealing performance and effectively prevents foreign matter from entering. The lighting adopts closed fluorescent lamps, easy to clean and disinfect, equipped with emergency lighting facilities, and the operating room lighting meets the requirements (main operation room ≥150LX, other areas ≥100LX).

       Workshop process conditions can meet the following aspects: ① personnel and materials entering the production area are separated; ② entering the clean area is equipped with facilities such as shoe changing, hand cleaning, changing clothes, buffering hand disinfection; ③ materials entering the clean area have dust removal and removal Packaging, inner packaging cleaning and disinfection, ultraviolet light irradiation and other buffer procedures; ④ 10,000-level clean area, 100,000-level clean area and general production area are equipped with corresponding levels of sanitary ware storage and appliance storage room; ⑤ production area is provided Safety exits and safety doors for easy evacuation; ⑥ The air-conditioning purification system has been verified according to specifications. Adjacent rooms of different cleanliness levels in the clean zone are installed with differential pressure meters and temperature and humidity meters, and cleanliness with regular monitoring of dynamic conditions is developed. The system of conditions, the recycling of purified air strictly adopts effective measures to avoid pollution and cross-contamination, dusting rooms such as weighing, dust collection, mixing, etc. are equipped with dust removal facilities, and local exhaust ducts are equipped with anti-backflow devices; ⑦ Purified water system and water for injection system are strictly verified according to the GMP requirements of veterinary drugs to ensure that process water meets the standards.

       The workshop is equipped with production equipment suitable for the production of products. The selection and design of workshop equipment all meet the production scale and process requirements. The main equipment is equipped with a secondary reverse osmosis pure water machine (2T / h), a column-type multi-effect distilled water machine (500L / h), a bottle washing machine, a rubber stopper aluminum cap cleaning and sterilizing machine, a potting machine, and a horizontal type. Rectangular pressure steam sterilizer, liquid distribution tank and chemical liquid pipeline, reaction kettle, high-speed centrifuge, nanofiltration unit, spray dryer, mixer, labeling machine, QR code printer group, etc. The equipment operation and performance are confirmed to meet the requirements of veterinary drug GMP.

       The number of workshop production staff is adapted to production. There is 1 head of production management section, 1 technical manager of injection workshop, and 1 technical manager of raw material production workshop. There are 8 injection production lines and 8 raw material production lines.

       The head of the production management section is held by professional and technical personnel with 21 years of experience in drug production management. The main posts of the workshop are directly engaged in veterinary drug production operations and quality inspection. All personnel have a high school education or above, and have certain theoretical knowledge and practical operation experience. They have received post training and health checks.