摘要
从药品生产质量管理法规规定及质量管理理论角度对药品生产六大系统检查的基本逻辑进行论述,从药品检查实践方面对质量管理系统、生产系统、设施与设备系统、实验室控制系统、物料系统、包装与标签系统等各系统的基本要求、检查重点和常见问题进行分析与明确。结合我国目前法规规定,探讨了基于药品生产六大系统的检查在各类药品生产监督检查中的应用,提出了以促进检查资源的高效使用为目的,基于质量风险管理原则和药品生产六大系统确定检查深度与广度的考虑,以期为各类药品检查及企业内外部审计的组织与实施中提供参照。
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.
作者
颜若曦
YAN Ruo-xi(Center for Food and Drug Inspection of NMPA,Beijing 100044)
出处
《中国药物评价》
2022年第5期431-435,共5页
Chinese Journal of Drug Evaluation
关键词
药品检查
质量风险管理
六大系统
生产质量管理
Drug inspection
Quality risk management
Six systems
Good manufacturing practices(GMP)
