摘要
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。
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.
出处
《中国药房》
CAS
CSCD
2012年第5期395-397,共3页
China Pharmacy
基金
国家自然科学基金资助项目(71063011)
作者简介
王力,讲师,硕士。研究方向:卫生管理、农村药品管理。电话:0791-7118861。E-mail:wangli0550@163.com;通讯作者:王素珍,教授,硕士研究生导师。研究方向:卫生管理、农村药品管理。电话:0791-7118861。E-mail:wsz64@163.com
