FDA对我国药品生产企业检查分析

Analysis of FDA inspection on pharmaceutical manufacturing industry in China

本文对FDA药品检查的基本政策、一般程序与要求、检查结果处理及检查警告信制度进行了分析研究,通过对近年来FDA对我国境内药品生产企业检查后发出的警告信及国家药品监督管理局受邀对FDA药品检查进行的观察检查中发现的缺陷情况进行了分类统计分析,明确了FDA药品检查的基本要求与程序、结果处理方式及其警告信作用与框架;总结了检查观察中FDA检查品种的主要类别及变化趋势,识别出我国境内药品生产企业在FDA检查中存在的主要缺陷分布情况及常见问题,以期为我国药品检查工作的进一步提升及更好地为药品监管进行检查技术支持提供参考与建议,为我国制药行业质量管理能力的不断提高提供借鉴与建议。

This study analyzed the basic policies,general procedures and requirements,handling of FDA drug inspection results and Warning Letter system.A statistical analysis was conducted on the FDA Warning Letters and FDA inspection observations in which National Medical Products Administration was invited to observe FDA's drug inspection of Chinese drug manufacturers in recent years.Based on these analyses,the basic requirements and procedures of FDA drug inspections and the function and framework of Warning Letter system are further clarified.The distribution of major observations and common problems existing in FDA inspection of Chinese drug manufacturers are identified,and the main trends in categories and varieties found in FDA inspection observations was summarized.It provides reference and suggestions for improving drug inspection in China,providing better inspection technical supports to drug administration,as well as improving the quality management abilities of pharmaceutical industry.