关于药品冷链系统验证的探讨

目的:为我国药品生产与经营企业实施冷链物流提供参考。方法:分析我国药品冷链物流现状及冷链系统验证的意义,借鉴国外冷链系统验证的理念对冷链系统验证的基本程序进行介绍。结果与结论:我国药品冷链物流的建设仍处于初级阶段,冷链系统验证是确保冷链药品能够始终符合温度控制要求的基本前提,冷链系统验证的基本程序包括需求识别、冷链开发、冷链执行三个阶段。需求识别中应重点考虑药品的稳定性及冷链运输过程;冷链开发作为冷链系统验证的主体,包括设计确认、运行确认与性能确认三个阶段;药品的冷链运输应在冷链系统验证完成及冷链系统批准后执行。

Discussion of Cold Chain System Qualification for Drugs

ABSTRACT OBJECTIVE： To provide reference for the implementation of cold chain logistics in pharmaceutical production and enterprises in China. METHODS： The situation of cold chain logistics and the significance of cold chain system qualification were analyzed in China. The basic procedure of cold chain system qualification were introduced according to the advanced concept of cold chain system qualification from abroad. RESULTS ＆ CONCLUSIONS： The construction of cold chain logistics is still on the initial stage in China; cold chain system qualification is the basic premise that cold chain drugs always fit with temperature require- ments. The procedure of cold chain system qualification includes requirements identification, the development of cold chain and the implementation of cold chain. Products stability and transportation process should be considered during the process of requirement identification. The development of cold chain is main body of cold chain qualification, including design identification, operation identification and performance identification. Cold chain transportation should be conducted after cold chain qualification and ap- proving cold chain system.