Article 43 An enterprise shall have a business place and warehouse suitable for its drug business scope and scale.
Article 44 The site selection, design, layout, construction, renovation and maintenance of warehouses shall meet the requirements of drug storage and prevent drug contamination, cross-contamination, confusion and errors.
Article 45 The drug storage operation area and auxiliary operation area shall be separated from the office area and living area by a certain distance or take isolation measures.
Article 46 The scale and conditions of the warehouse shall meet the requirements of reasonable and safe storage of drugs, and meet the following requirements to facilitate storage operations:
(a) the environment inside and outside the warehouse is clean and tidy, without pollution sources, and the ground in the reservoir area is hardened or afforested;
(2) The interior wall and roof of the warehouse are smooth, the ground is flat, and the doors and windows are tightly structured;
(3) The warehouse has reliable safety protection measures, which can control the entry of irrelevant personnel and prevent drugs from being stolen, replaced or mixed with counterfeit drugs;
(four) measures to prevent outdoor loading and unloading, handling, receiving, shipping and other operations from being affected by abnormal weather.
Article 47 A warehouse shall be equipped with the following facilities and equipment:
(1) Equipment for effectively isolating drugs from the ground;
(2) Equipment that is protected from light, ventilation, moisture, insects and rats;
(3) Equipment for effectively regulating temperature and humidity and indoor and outdoor air exchange;
(4) Equipment for automatically monitoring and recording the temperature and humidity of the warehouse;
(five) lighting equipment that meets the requirements of warehousing operations;
(6) Operating areas and equipment for picking, LCL delivery and re-inspection;
(seven) the storage place of packaging materials;
(eight) special places for acceptance, delivery and return;
(9) Special storage place for unqualified drugs;
(10) Having storage facilities that meet the requirements of drugs under special state administration.
Forty-eighth Chinese herbal medicines, Chinese herbal pieces, there should be a special warehouse and maintenance workplace, Chinese herbal medicines purchased directly from real estate should be set up Chinese herbal medicine sample room (cabinet).
Article 49 The storage and transportation of refrigerated and frozen drugs shall be equipped with the following facilities:
(a) there are cold storages suitable for its business scale and variety, and two or more independent cold storages shall be equipped for storing vaccines;
(2) Equipment for automatic monitoring, display, recording, adjustment and alarm of cold storage temperature;
(three) the standby generator set or double circuit power supply system of refrigeration equipment in cold storage;
(4) For drugs with special low-temperature requirements, facilities and equipment that meet their storage requirements shall be provided;
(five) refrigerated trucks and car refrigerators or incubators and other equipment.
Article 50 A closed means of transport for goods shall be used for transporting drugs.
Article 51 refrigerated trucks, vehicle-mounted refrigerators and incubators for transporting refrigerated and frozen drugs shall meet the requirements of temperature control during drug transportation. The refrigerated truck has the functions of automatically regulating and controlling temperature, displaying temperature, storing and reading temperature monitoring data; Refrigerator and incubator have the functions of external display and temperature data collection in the box.
Article 52 Regular inspection, cleaning and maintenance of storage and transportation facilities and equipment shall be carried out by special personnel, and records and files shall be established.
Do electronic account management.