The 2013 version of the Code of Practice for the Quality Management of Pharmaceutical Business has been considered and passed by the Ministry of Health's ministerial meeting on November 6, 2012, and has come into effect from June 1, 2013 onwards.
I. 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 1,500 square meters, medium-sized enterprises not less than 1,000 square meters, small enterprises not less than 500 square meters.
2, the warehouse environment requirements: the warehouse floor should be level, no water and weeds, no pollution sources.
3, the warehouse should be able to meet the following requirements:
(1) site requirements: drug storage operations, auxiliary work areas, 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 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 a special library of zero cargo weighing (area). The library area should be set up a clear sign.
Note: the above large-scale wholesale and retail drug chain enterprises, refers to the annual drug sales of more than 200 million yuan; medium-sized enterprises refers to the annual drug sales of 50 million yuan to 200 million yuan; small enterprises refers to the annual drug sales of less than 50 million yuan;
Two, the warehouse facilities and equipment requirements
1, to maintain a certain distance between the drugs and the ground. The ground to maintain 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 and pest control, rodent, bird and other equipment;
5, in line with the requirements of the safety of electricity lighting equipment, hazardous materials warehouse lighting should be made explosion-proof treatment;
6, suitable for the workplace and packaging materials, such as zero and consolidated shipment of storage space and equipment.
7, drug wholesalers and retailers according to 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 35 ~ 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.
Three, the business premises of the facilities, equipment and requirements
1, drug retailers should have with the scale of operation of the business premises and drug warehouses, 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 the retail of drugs required:
(1) large retailers business premises area of 100 square meters, 30 square meters of warehouses;
(2) medium-sized retailers business premises area of 50 square meters, 20 square meters of warehouses;
(3) small retailers business premises area of 40 square meters, 20 square meters of warehouses;
(4) retail chain stores business premises area of 40 square meters.
3, drug retailers business premises and drug warehouses should be configured equipment:
(1) drug retailers and retail chain stores should be spacious, clean business premises, business shelves, counters are available, sales cabinet sign conspicuous;
(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 as necessary.
(6) equipment to maintain a certain distance between the drugs and the ground;
(7) drug dust, moisture, pollution and pest control, rodent, mildew and other equipment;
the operation of traditional Chinese medicine tablets required for the allocation of prescriptions and clinical concoctions of the equipment;
4, drug retail chain enterprises should set up distribution centers compatible with the scale of operations, its warehousing, acceptance, inspection, maintenance, etc.;
3, the distribution center should be set up by the pharmaceutical retail chain 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, easy to carry out the distribution activities of the distribution site.
Four, 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. Pharmaceutical laboratory area, large enterprises not less than 150 square meters; medium-sized enterprises not less than 100 square meters; small enterprises not less than 50 square meters.
3, drug testing room should be carried out chemical determination, instrumental analysis and other testing programs, and equipped with the size of the enterprise and business varieties of instruments and equipment appropriate.
(1) small 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 - on the basis of the configuration of small enterprises, increase the automatic spinning instrument, ultraviolet spectrophotometer, biochemical incubator, autoclave, high temperature table, ultra-clean bench, high power microscope. The operation of Chinese herbal medicines, traditional Chinese medicine tablets should also be configured biomicroscope.
(3) large enterprises - in small and medium-sized enterprises on the basis of the configuration, increase the tablet dissolution meter, vacuum drying oven, constant temperature wet incubator.
V. Receiving and inspection and maintenance room
1, pharmaceutical wholesale and retail chain enterprises should be set up in the warehouse receiving and inspection and maintenance room, its area requirements should generally be reached: large-scale enterprises of not less than 50 square meters; medium-sized enterprises of not less than 40 square meters; small enterprises of not less than 20 square meters;
2, equipment requirements: receiving and inspection and maintenance room should 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 **** instrumentation for the hemp fly cultivation one thousandth of the balance, clarity detector, standard colorimetric solution.
Enterprises operating Chinese herbal medicines, Chinese medicine tablets should also be configured with a moisture meter, ultraviolet fluorescent lamps, dissecting mirrors or microscopes.