关键词: font-size:medium, ">药品检查；质量风险管理；六大系统；生产质量管理

Abstract: The study discussed the basic logic of the six major system inspections of Medicine Manufacture from the perspective of good manufacture practices and quality management theory. From the aspect of drug inspection practice， the basic requirements， inspection key points and common problems of pharmaceutical quality system， production system， facilities and equipment system， laboratory control system， materials system， packaging and labeling system were analyzed and clarified. Combined with the current regulations， the study discussed the application of six major systems inspection method in the all kinds of supervision inspections of medicine manufacture.In order to promote the efficiency of inspection resources， it suggest the depth and breadth of inspection could be determined based on the principles of quality risk management and the six major systems of medicine manufacture. It was expected to provide reference for drug inspections and internal and external audits of manufacturers.

Key words: font-size:medium, ">Drug inspection； Quality risk management； Six systems； Good manufacturing practices (GMP)