FDA医药产品cGMP警告信分析

Analysis of FDA Issued Warning Letters on cGMP for Medical Products

目的:研究FDA发布的医药产品cGMP相关的警告信。方法:采用统计分析的方法,对FDA医药产品cGMP相关的警告信进行分析讨论,推测FDA对医药产品质量管理体系监管重点和意图。结果与结论:FDA警告信的内容非常有价值,对把握世界医药产品质量管理的趋势和改进质量管理水平有很大帮助。

Objective： To research the warning letter from US FDA about pharmaceutical product CGMP. Method： Statistic method is employed to analyze and discuss the warning letter from US FDA about pharmaceutical product CGMP. Thus, the supervision emphasis and intent of quality management system of FDA are presumed. Result and discussion： The content of FDA warning letter is valuable, which is quite helpful in grasping the trend of pharmaceutical product quality management in world and in improving our quality management level.