Factory environment
According to the requirements of GMP, the factory is located in Shexian Economic Development Zone, the local area is subtropical monsoon climate, the average annual temperature is 16.4℃, the annual precipitation is 1477 mm, and the surrounding air, water sources are without pollution sources. There is no exposed soil in the factory, the green area accounts for 25%. The overall layout of the factory is reasonable, the people and logistics are relatively separate. The road side is mainly lawn, and In order to meet the requirements of GMP,no plants that emit pollen or have adverse effects on drug production is cultivated
Cleaning workshop
According to the "Clean workshop design code for the Pharmaceutical Industry", independent clean workshop is designed for different products. The air purification level is 100000 (GRADE D,ISO8), which can meet the requirements of production process and air cleanliness level. The layout is reasonable and can prevent contamination and cross-contamination.
Laboratory conditions
The company's laboratory construction area is about 500 square meters, with microbial testing room, balance room,Standardization room, sample room, physical and chemical operation room, heating room, instrument analysis room, etc. The laboratory has reasonable layout, with effective measures such as drying, moisture-proof, anti-vibration, anti-static and temperature regulation. The inspection site is suitable for the production scale, variety and inspection requirements, and the testing instruments and equipment can meet the requirements of drug quality inspection.
Equipment
The design, selection and installation of equipment meet the requirements of production process. The production equipment in direct contact with the product is made of stainless steel, and the surface in contact with the material is smooth, easy to clean or disinfect, corrosion resistant, and does not react or adsorb or release substances to the product. The main fixed pipe connected to the equipment shall indicate the name of the contents and the direction of flow conspicuously.
