美国FDA药品监督检查与抽验模式分析及启示

目的:为进一步完善我国药品抽验模式提供参考。方法:通过查阅相关文献对美国FDA的药品监督检查与抽验机构和模式进行分析,并结合相关案例,探讨此种模式对我国的启示,并提出建议。结果与结论:我国应重视企业的《药品生产质量管理规范》(GMP)检查,特别是实验室检查;药品质量抽验与GMP和《药品经营质量管理规范》(GSP)检查结合;贯彻质量风险评价为核心的理念;对监督检查中发现有质量问题的药品应进行原因追溯。美国FDA监督检查与抽验结合的过程控制理念很值得我国学习与借鉴。

Analysis and Inspiration of FDA Drug Supervision and Inspection, Sampling and Testing Model

OBJECTIVE： To provide reference for drug sampling and testing model in China. METHODS： Through literature research, FDA drug supervision and inspection, sampling and testing institution and model were analyzed and inspiration and sug- gestion to our country were put forward on the basis of related cases. RESULTS ＆ CONCLUSIONS： We should pay attention to GMP inspection of enterprises, especially the inspection of laboratory; sampling and testing of drug quality should be combined with the inspection of GSP; quality risk evaluation is regarded as the important point of inspection; the reasons for the problems of drug quality are traced. The idea and model of FDA drug supervision and inspection, sampling and testing are good examples for us to study and learn.