In vitro diagnostic reagent business enterprises in the selection of the warehouse should pay attention to:
1, should be set up in line with the requirements of the diagnostic reagent storage warehouse, the area should be compatible with the scale of operation, but shall not be less than 60 square meters, and the environment in the warehouse area is clean and tidy, no pollution sources; Diagnostic reagent storage operation area should be effectively isolated from other areas such as business, office; warehouse walls, roofs and floors should be clean and smooth, with tightly structured doors and windows.
2, residential premises shall not be used as a warehouse.
In vitro diagnostic reagent business enterprise cold storage requirements are as follows:
Should be set up to store diagnostic reagents cold storage, its volume should be compatible with the scale of operation, but not less than 20 cubic meters. Cold storage should be equipped with automatic monitoring, regulation, display, recording temperature conditions and automatic alarm equipment, standby generator set or install dual circuit, standby refrigeration unit. And must meet the GSP certification requirements.
The warehouse storing diagnostic reagents should have the following facilities and equipment:
1, diagnostic reagents and the ground between the effective isolation of the equipment;
2, ventilation and to avoid direct sunlight equipment;
3, effective control, detection of temperature and humidity equipment;
4, in line with the requirements of the storage operation of the lighting equipment;
5, non-compliant diagnostic reagents, returned diagnostic reagents. Qualified diagnostic reagents, returned diagnostic reagents dedicated storage area or facilities and equipment;
6, packaging materials storage space and equipment;
7, the quality status of diagnostic reagents should be implemented color-coded management, to be determined diagnostic reagents for yellow, qualified diagnostic reagents for green, unqualified diagnostic reagents for red.
In vitro diagnostic reagent business enterprises and other facilities and equipment requirements:
1, there should be compatible with the scale of operation and business varieties, in line with the requirements of the characteristics of the drug storage temperature and other transportation facilities and equipment.
2, there should be a computer management information system to meet the diagnostic reagent management process and quality control requirements, and can be realized to accept the local drug supervision and management department supervision conditions.
3, should be used to check the facilities and equipment, maintenance, calibration, repair, cleaning to establish a file.
See the Drug Administration on the issuance of in vitro diagnostic reagents business enterprises (wholesale) acceptance criteria and start-up application procedures.