关于GSP中药品冷链管理条款修订的建议

目的:为《药品经营质量管理规范》(GSP)修订提供建议,保证药品冷链管理过程中的药品质量。方法:通过查阅药品流通及冷链技术规范等资料,实地考察药品冷链管理和有关冷链物流企业的管理情况,分析现行GSP中有关冷链管理规定存在的安全隐患。结果:GSP有关规定主要存在设施设备准入要求低、缺乏规范操作标准、冷链数据监管不严、未强调对设施设备的验证等问题,从而不能充分保证冷链药品的质量安全。结论:我国GSP的修订必须从设施设备、收验、储存养护、发货、运输、人员、验证7个方面制定具体的操作规范。

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 man- agement 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.