(a), the 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 less than 500M2.
2, the requirements of the warehouse environment: the ground in the warehouse area should be level, no water and weeds, no pollution sources.
3, the warehouse should be able to meet the following requirements: library 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 and meet the drug storage requirements of the warehouse. Storehouse walls, roof and ground 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;
(2), 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 retail business premises area of 50M2, warehouse 20M2;
③ small retailers business premises area of 40M2, warehouse 20M2;
④ retail chain 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 are ready to sell cabinets marked conspicuously;
②
drugs Retail enterprises and retail chain stores should be equipped with intact scales and 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 chains of sales of special management of medicines should be configured to store the special management of the special drugs in special cabinets and custody of the equipment, tools, etc.
④ necessary drug testing, inspection, maintenance and repair of the drug. ④ Necessary drug testing, acceptance, maintenance equipment;
⑤ Testing and regulating temperature and humidity equipment;
⑥ Maintaining a certain distance between the drugs and the ground equipment;
⑦ Drugs, dust, moisture, pollution and insect, rodent, mildew and other equipment;
Medicine tablets required to operate the dispensing of prescriptions and prescription concoctions of the equipment;
4 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, easy to carry out the distribution activities of the distribution site.
(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 wholesalers 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 and 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.
3, drug testing room should be carried out in the chemical determination, instrumental analysis and other testing programs, and is equipped with the size of the enterprise and business varieties of instruments and equipment appropriate.
①Small enterprises - the configuration of one-ten-thousandth analytical balance, acidity meter, electric thermostatic drying oven, thermostatic water bath, tablet disintegration meter, clarity detector. Business Chinese herbs and tablets, should also be equipped with moisture meter, ultraviolet fluorescent lamps and microscopes.
② medium-sized enterprises - in small enterprises on the basis of the configuration, increase the autorotator, ultraviolet spectrophotometer, biochemical incubator, autoclave
sterilization kettle, high-temperature table, ultra-clean bench, high-powered microscope. The operation of Chinese herbal medicines, traditional Chinese medicine should also be equipped with biological microscope
mirror.
③ large enterprises - in small and medium-sized enterprises on the basis of the configuration, increase the tablet dissolution tester, vacuum drying oven, constant temperature wet incubator.
(E), acceptance testing and maintenance room
1,
Drug wholesale and retail chain enterprises should be set up in the warehouse acceptance testing and maintenance room, and its area requirements should be generally: large enterprises not less than 50 M2; medium-sized enterprises no less than 40 M2; small enterprises no less than 20 M2;
2,
Equipment requirements: Acceptance Testing and Maintenance room should be Have the necessary moisture-proof, dust-proof equipment. If the warehouse is not set up in the pharmaceutical inspection room or can not be used with the inspection room *** with instruments and equipment for the hemp fly cultivation one-thousandth of a balance, clarity tester, standard colorimetric solution. Enterprises operating Chinese herbal medicines, Chinese medicine tablets should also be configured with moisture meter, ultraviolet fluorescent lamps, anatomical mirrors or microscopes.