Discussion on the Main Risk of Clean Clothes in Drug GMP Management
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.
万方数据
维普
