Article 43 of the enterprise shall have its pharmaceutical business scope, scale of operation of the business premises and warehouse.
Article 44 of the depot site selection, design, layout, construction, remodeling and maintenance should be in line with the requirements of the drug storage, to prevent contamination of drugs, cross-contamination, confusion and error.
Article 45 of the drug storage operation area, auxiliary operation area should be separated from the office and living areas at a certain distance or have isolation measures.
Article 46 of the size and conditions of the warehouse should meet the reasonable and safe storage of drugs, and to meet the following requirements to facilitate storage operations:
(a) inside and outside the warehouse environment is clean and tidy, no source of contamination, hardening of the ground in the warehouse area or greening;
(b) the warehouse walls, roof clean, the ground is smooth and the structure of the doors and windows tight;
(c) the warehouse There are reliable security measures to enable the entry of unrelated personnel to implement controlled management to prevent theft, replacement or mixing of counterfeit medicines;
(d) there are measures to prevent outdoor loading and unloading, handling, receiving, shipping and other operations affected by unusual weather.
Article 47 of the warehouse shall be equipped with the following facilities and equipment:
(a) effective isolation between the drugs and the ground;
(b) light, ventilation, moisture, insect and rodent-proof equipment;
(c) effective regulation of temperature and humidity and indoor and outdoor air exchange equipment;
(d) automatic monitoring and recording of temperature and humidity in the warehouse equipment;
(v) lighting equipment that meets the requirements of storage operations;
(vi) operational areas and equipment for zero picking, consolidation and shipment operations and review;
(vii) storage places for packaging materials;
(viii) special places for acceptance, shipment, and return of goods;
(ix) special places for storage of substandard medicines;
(x) special places for storage of substandard medicines;
(x) special places for storage of substandard medicines;
(xi) special places for storage of substandard medicines;
(j) the operation of special management of drugs have storage facilities in line with national regulations.
Article 48 of the business of Chinese herbal medicines, Chinese medicine tablets, there should be a dedicated warehouse and maintenance workplace, direct acquisition of real estate Chinese herbal medicine should be set up Chinese medicine sample room (cabinet).
Article 49 of the storage, transportation of refrigerated, frozen drugs, should be equipped with the following facilities and equipment:
(a) its scale of operation and varieties of cold storage, storage of vaccines should be equipped with more than two independent cold storage;
(b) for the cold storage of temperature automatic monitoring, display, recording, regulation, alarm equipment;
(c) cold storage Refrigeration equipment backup generator sets or dual circuit power supply system;
(d) special low-temperature requirements of drugs, should be equipped with facilities and equipment to meet its storage requirements;
(e) refrigerated trucks and car refrigerated boxes or heat preservation boxes and other equipment.