(a), warehouse and environmental requirements
1, the enterprise should have its scale of operation of the warehouse. Its area (floor area) should meet the following requirements: large enterprises not less than 1500M2, medium-sized enterprises not less than 1000M2, small enterprises not less than 500M2.
2, the requirements of the environment of the warehouse area: the floor of the warehouse area should be level, no water and weeds, no pollution sources.
3, the warehouse should be able to meet the following requirements: depot site and security requirements:
1) site requirements: drug storage operation area, auxiliary operation area, office life should be separated from a certain distance or isolation measures, loading and unloading operations should be roofed.
2) warehouse building requirements: the warehouse has a suitable classification of drugs for safekeeping and in line with the drug storage requirements of the warehouse. Storehouse walls, roof and floor clean, smooth, tightly structured doors and windows.
3) safety and fire prevention requirements: the warehouse should be in line with the requirements of the fire, safety measures.
4, the warehouse has a reasonable functional partition. Warehouse should be divided into a warehouse to be examined (area), qualified goods library (area), shipping library (area), non-qualified goods library (area), return library (area) and other specialized places, the operation of Chinese medicine tablets should also be divided into the zero cargo weighing special library (area). The library area should be set up a clear sign.
Note: the above large-scale wholesale and retail drug chain enterprises, refers to annual drug sales of more than 200 million yuan; medium-sized enterprises refers to annual drug sales of 50 million yuan to 200 million yuan; small enterprises refers to annual drug sales of less than 50 million yuan;
(B), warehouse facilities and equipment requirements
1, to maintain the drug and the ground a certain distance between the equipment;
2, light, ventilation and drainage equipment;
3, detection and regulation of temperature and humidity equipment;
4, dust, moisture, mildew, pollution, as well as insects, rodents, birds, and other equipment;
5, in line with the requirements of the safety of the electricity lighting equipment;
6, suitable for zero and consolidation The workplace and packaging materials and other storage places and equipment.
7, drug wholesalers and retailers in accordance with the storage requirements of the drugs operated, should be set up in different temperature and humidity conditions of the warehouse. Among them, the cold storage temperature should be 2 ~ 10 ℃; cool storage temperature does not exceed 20 ℃; room temperature of 0 ~ 30 ℃; the relative humidity of each warehouse should be maintained between 45 ~ 75%.
8, the storage of narcotic drugs, a class of psychotropic drugs, toxic drugs for medical use, emissive drugs should be special warehouses and have the appropriate security measures.
(C), business facilities, equipment and requirements
1, drug retailers should have a business premises and drug warehouses appropriate to the scale of operation, and the environment is clean, free of pollutants, temperature and humidity regulation equipment. Business premises, warehouses, office life and other areas of the enterprise should be separated.
2, the area of the business premises and warehouses of retail drug requirements:
① large retailers business premises area of 100M2, warehouse 30M2;
② medium-sized retailers business premises area of 50M2, warehouse 20M2;
3 small retailers business premises area of 40M2, warehouse 20M2;
④ retail chain stores business premises area of 40M2.
3, drug retailers business premises and drug warehouses should be configured with equipment:
① drug retailers and retail chain stores business premises should be spacious, clean, business shelves, counters, sales cabinets marked conspicuously;
② drug retailers and retail chain stores should be equipped with intact scales, as well as clean and hygienic drug transfer tools, packaging supplies, and configure low-temperature preservation of all products according to the need for refrigeration equipment;
③ retail enterprises and retail chain stores selling special management of drugs, should be configured to store special management of the drugs in the special cabinet and the storage of equipment, tools, etc.;
④ the necessary drug testing, acceptance and maintenance equipment;
⑤ equipment for inspection and adjustment of temperature and humidity;
6 equipment to maintain a certain distance between the drugs and the ground;
7 equipment to prevent dust, moisture, pollution and pests, rodents, mold and mildew of the drugs;
equipment for the dispensing of prescriptions and clinical concoctions required to operate traditional Chinese medicinal herbs;
4, the drug retail chain enterprises should set up a distribution center that is suitable for the scale of operation. Distribution center, its warehousing, acceptance, inspection, maintenance and other facilities require the same as the same size of the wholesale enterprises. Retail chain stores, product display, storage and other equipment requirements and retail enterprises with the same.
5, drug retail chain enterprises should set up a separate, convenient distribution activities to carry out the distribution of goods place.
(D), the drug testing room set up and requirements
1, the drug business sector with the scale and scope of operation of the drug testing department, and configure the appropriate testing instruments and equipment. Business of Chinese herbal medicine and Chinese medicine tablets should also set up Chinese medicine specimen room (cabinet).
2, drug wholesale and retail chain enterprises set up drug testing room should be used for instrumental analysis, chemical analysis, titrant calibration of special places, and for flammable, explosive, toxic and other environments such as the operation of the safety facilities and temperature, humidity and air-conditioning equipment. Drug testing room area, large enterprises not less than 150M2; medium-sized enterprises not less than 100M2; small enterprises not less than 50M2