Drug business quality management standard article 49 business refrigerated and frozen drugs, should be equipped with what facilities and equipment

Article 49 of the Drug Administration Quality Management Code states:

Article 49 The storage and transportation of refrigerated and frozen drugs shall 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 automatic monitoring of the temperature of the cold storage, display, recording, regulation, alarm equipment;

(c) cold storage refrigeration equipment, backup generator sets or dual-channel refrigeration equipment

(ii) for cold storage temperature automatic monitoring, display, recording, regulation, alarm equipment;

(iii) cold storage refrigeration equipment back-up generator or double circuit power supply system;

(iv) special low temperature requirements for drugs, should be equipped with facilities and equipment to meet the requirements of its storage;

(v) refrigerated trucks and trucks, such as refrigerated boxes or heat preservation box equipment.

So according to your situation: two or more independent cold storage; cold storage temperature automatic monitoring, display, recording, regulation, alarm equipment; cold storage refrigeration equipment backup generator set or double circuit power supply system; in line with the special low-temperature requirements of the drug storage requirements of the facilities and equipment; refrigerated trucks and car refrigerated boxes or heat preservation boxes and other equipment are required.