Analysis on FDA's CGMP Warning Letters of Medical Products
- VernacularTitle:FDA医药产品CGMP相关警告信分析
- Author:
Yi LIANG
;
Huimin WANG
- Publication Type:Journal Article
- Keywords:
Medical products;
CGMP;
Warning Letters
- From:
China Pharmacy
2007;0(25):-
- CountryChina
- Language:Chinese
-
Abstract:
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.
