全球制药企业检查缺陷情况分析和GMP检查策略

Inspection Deficiencies of Pharmaceutical Industry Worldwide and GMP Inspection Strategy

本文通过收集近年FDA、 MHRA、CFDI发布的药品GMP检查信息,对国内外检查缺陷的情况进行统计、分析和对比,并提出建议。从检查缺陷分布上看,上述检查机构存在共同点,主要包括偏差管理、文件规程制定/管理、数据完整性等问题。FDA引用频率最高的条款是质量控制部门履职及规程书面化,占比26.8%。MHRA引用频率最高的条款为偏差调查的根本原因分析,并制定、实施和评估对应的纠正和预防措施,占比83.6%。CFDI引用频率最高的条款是检验记录及检验方法确认,占比39.2%。文章通过分析缺陷情况,并提出解决建议希望为国内药品监管和企业管理提供参考。

By collecting the GMP inspection information of drugs released by FDA, MHRA and CFDI in recent years, statistics, analysis and comparison of inspection deficiency at home and abroad were made, and suggestions were put forward. In terms of the distribution of inspection deficiency, the above institutions mentioned similar opinions, mainly including deviation management, document procedure formulation/management, data integrity and other issues. The clauses with the highest frequency of deficiency cited by FDA, accounting for 26.8 %, were the performance of the quality control department and the written procedures. The most frequently cited clause of the MHRA for deficiency was that analyze the root cause of deviation, Appropriate corrective actions and preventative actions(CAPAs) should be identified、taken and assessed in response to investigations, accounting for 83.6 %. The clauses with the highest frequency of deficiency cited by CFDI are the confirmation of testing records and test methods, accounting for 39.2 %. This paper analyzes these situations and puts forward suggestions the hope of providing reference for domestic drug supervision and enterprise management.