Suggestions on Item Revision of Drug Cold-chain Management in GSP

OBJECTIVE:To provide suggestions for GSP revision,and to ensure the quality of drug during the cold-chain management process.METHODS:Referring to drug circulation and cold-chain technical specifications,drug cold-chain management and management situation of relevant cold-chain logistics enterprise were investigated on the spot,the safety risk of the current cold-chain management standard was analyzed.RESULTS:The problems of related regulations of GSP mainly existed,such as low inclusion criteria,lack of standardized operation standard,relaxed cold-chain data supervision,no emphasis on facilities validation,thus the quality and safety of cold-chain drugs cannot be guaranteed fully.CONCLUSIONS:The operation standards of GSP revision should be formulated in terms of facilities,check,storage and maintenance,delivery,transportation,personnel,validation.