目前藥品生產(chǎn)企業(yè)在藥品生產(chǎn)質(zhì)量管理規(guī)范的實(shí)施過(guò)程中，生產(chǎn)場(chǎng)地消毒管理方面存在的問(wèn)題比較突出。消毒相關(guān)缺陷出現(xiàn)頻率較高的問(wèn)題包括消毒策略制定、消毒驗(yàn)證、消毒程序文件、消毒執(zhí)行、消毒劑管理。對(duì)藥品生產(chǎn)企業(yè)藥品生產(chǎn)現(xiàn)場(chǎng)的消毒相關(guān)缺陷進(jìn)行分析，并提出改進(jìn)建議，以期為藥品生產(chǎn)企業(yè)提升消毒管理提供借鑒。

At present, there are prominent problems in disinfection management of drug production sites in the implementation of GMP by pharmaceutical manufacturers. Disinfection related deficiencies occur frequently, including disinfection strategies formulation, disinfection validation, disinfection procedure documents, disinfection execution, and disinfectant management. This article analyzes the disinfection related deficiencies in drug production sites of pharmaceutical manufacturers and proposes improvement suggestions, in order to provide reference for pharmaceutical manufacturers to improve disinfection management.

R954