FDA医药产品CGMP相关警告信分析

Analysis on FDA's CGMP Warning Letters of Medical Products

目的：为我国企业把握世界医药产品质量管理的趋势和改进质量管理水平提供参考。方法：对2002-2006年间美国食品与药品管理局（FDA）发布的医药产品现行药品生产质量管理规范相关的警告信进行统计分析，探讨FDA对医药产品质量管理体系的监管重点和意图。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。我国企业可以从FDA对医药产品的监管重点、意图和现场检查等方面来整理思路，发现企业在质量管理体系方面存在的问题和进行改进的方法。

OBJECTIVE： To provide references for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level. METHODS： FDA＇s CGMP Warning Letters on medical products issued by the USA during 2002-2006 were analyzed statistically, and FDA＇s emphasis and intent on quality management system of medical products was discussed. RESULTS ＆ CONCLUSIONS： The contents stated in FDA Warning Letters are of great importance for Chinese enterprises to grasp the trend of quality management of worldwide medical products and to improve the quality management level, Chinese enterprises can probe into the problems and solutions of quality management of medical products by analyzing FDA＇s emphasis and intent on quality management system of medical products as well as field investigation.