FDA药品CGMP警告信统计分析

Statistical Analysis of Drug CGMP Warning Letters of FDA

目的:了解美国药品生产质量管理法规关注重点,把握FDA药品CGMP国际检查趋势,帮助我国企业在实施CGMP过程中进行借鉴和提高。方法:统计分析2011-2016年FDA对国外企业发布的145封药品CGMP警告信,重点解析2016年发布的43封警告信缺陷项,归纳警告信中经常发生的缺陷项目。结果与结论:2016年FDA对国外企业发布的药品CGMP警告信数量显著增加,印度和中国(大陆)企业成为检查重点。实验室控制、质量管理、厂房与设施设备三大系统是检查关注的焦点,数据可靠性问题突出。制剂与原料药生产企业在生产控制、实验室控制和质量管理方面的缺陷存在较大差异。

Objective： To understand the key points of laws and regulations of US pharmaceutical production quality management, to grasp the trends of drug current good manufacturing practice（CGMP） international inspection of FDA and to provide references for improving the quality management level in the implementation of CGMP of enterprises in China. Methods： 145 drug CGMP warning letters issued to foreign enterprises by FDA from 2011 to 2016 were analyzed statistically, emphasizing on analyzing the defect items of 43 warning letters issued in 2016 and summarizing the frequent defects in the warning letters. Results and Conclusion： The number of drug CGMP warning letters issued to foreign enterprises by FDA increased dramatically in 2016. Enterprises from India and China's Mainland became the focuses of the inspection. Three systems including laboratory control system, quality management system and plant and facility system were the focuses of inspection. The problem of reliability of data was serious. There were great differences in the production control, laboratory control and quality management between the preparation and active pharmaceutical ingredient manufacturing enterprises.