关于药品GMP管理中洁净服存在主要风险点的探讨

Discussion on the Main Risk of Clean Clothes in Drug GMP Management

对于药品生产来说,为了减少人员对洁净环境的污染,同时考虑到操作员工健康防护的需求,所有进入洁净区人员均需要穿戴洁净服,本文基于中国GMP、EUGMP、FDAcGMP等法规要求,同时结合多年在GMP检查过程中洁净服管理方面的经验,从洁净服全生命周期管理中的关键点和策略进行剖析,以评估洁净服使用过程中可能带来的潜在质量风险,为业界对洁净服规范化管理提供参考。

For drug production,in order to reduce the pollution of personnel to the clean environment,and taking into account the needs of the health protection of the operating staff,all people entering the clean area need to wear clean clothes.Based on the requirements of GMP,EU GMP,FDA cGMP and other regulations in China,combined with years of experience in the management of clean clothes in the GMP inspection process,this paper analyzes the key points and strategies in the whole life cycle management of clean clothes,so as to evaluate the potential quality risks that may be brought about in the use of clean clothes,and provide reference for the industry to standardize the management of clean clothes.