国家药品监督管理局启动了药品检查合作计划(PIC/S)预加入申请,将有助于完善我国药品GMP标准。《PIC/S GMP缺陷分级指南》是直接影响药品GMP检查结论的关键性文件,其中许多细节要求值得我国药品检查机构和检查员关注。基于对《PIC/S GMP缺陷分级指南》的分析,结合国内外GMP缺陷分级标准规定和具体实践,分析了药品GMP缺陷分级决策流程和风险评估,并进行了药品GMP缺陷分级示例和案例分析,以促进我国药品GMP检查进一步与国际接轨。

NMPA has officially launched the PIC/S organization pre-application, which will help improve China's drug GMP standards.“PIC/S Guidance on Classification of GMP Deficiencies” is a critical guidance that directly affect the conclusion of GMP inspection,and many detailed requirements in the guidance are worthy for attention by medicine inspection institutions and inspectors. Based on the study of “PIC/S Guidance on Classification of GMP Deficiencies”, analyzing domestic and foreign GMP deficiencies classification standards and practices, this article analyzes the decision-making process and risk assessment of drug classification of GMP deficiencies, and provides examples and case analysis to promote China's drug GMP inspection to further align with international standards.

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