基于药品经营质量管理规范的药品冷库温度验证分析  

Analysis of temperature validation of GSP-based cold storage for pharmaceuticals

作　　者：王霞 庞逸辉 张光华 江志杰 宣泽 Wang Xia;Pang Yihui;Zhang Guanghua;Jiang Zhijie;Xuan Ze(Beijing Institute for Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drug,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《首都食品与医药》2025年第9期154-157,共4页Capital Food Medicine

摘　　要：目的 通过温度验证确定药品冷库温度分布是否符合储存要求,给出最佳储存区域、开关门及断电时间,为药品冷库日常运行提供依据。方法 参照《药品经营质量管理规范》附录5及《医药产品冷链物流温控设施设备验证性能确认技术规范》GB/T34399-2017技术要求,对5个药品冷库连续2年进行满载温度分布特性测试、开关门测试和断电测试,并对数据进行分析。结果 与结论确立了5个药品冷库的最佳储存区域,给出了各自的开关门及断电时间,并对数据进行了分析及建议。Objective To determine whether the temperature distribution of drug cold storage meets the storage requirements through temperature verification,and to give the optimal storage area,door opening and closing and power-off time,so as to provide a basis for the daily operation of drug cold storage.Methods With reference to Appendix 5 of the Code of Practice for the Quality Management of Pharmaceutical Business and the Technical Specification for Verification of Performance Confirmation of Temperature Control Facilities and Equipment for Cold Chain Logistics of Pharmaceutical Products GB/T34399-2017 Technical Requirements,we conducted the full-load temperature distribution characteristic test,open and close door test,and power-off test of 5 pharmaceutical cold storages for 2 consecutive years,and analyzed the data.Results and Conclusion The optimal storage areas of the five pharmaceutical cold rooms were established,the respective opening and closing door and power-off times were given,and the data were analyzed and suggested.

关 键 词：GSP温度验证 冷库 温度分布特性 开关门试验 断电试验 

分 类 号：R927.1[医药卫生—药学]