美国FDA医药产品CGMP相关警告信统计分析及启示

Statistical Analysis and Implication of FDA's Warning Letters on CGMP for Medical Products

对2012年—2016年上半年美国FDA发出的人用产品(尤其是医药产品)动态生产质量管理规范(CGMP)相关警告信进行统计分析,总结并解析这类警告信中所提及的常见缺陷项目,探讨FDA对医药产品的监管重点,同时提出对我国医药企业的启示,为我国企业把握世界医药产品质量管理的趋势和改进自身生产质量管理水平,提供参考。

The statistical analysis of warning letters on CGMP fbr products for human use, especially medical products, issued by FDA from 2012 to the first half of 2016 was performed. The common defects mentioned in those warning letters were summarized and analyzed. The regulatory focus of FDA on medical products was discussed and the implication to Chinese phamaaceutical enterprises was revealed, so as to provide some references tbr Chinese enterprises to understand the global trend of medical product quality management and to improve their level of production quality management.