摘要
目的:探索国内外GMP管理体系结构的差异,为完善我国GMP制度提供参考。方法:立足我国2010年新修订GMP,结合WHO,PIC/S的生产质量管理规范,选取欧盟、美国、日本的动态GMP标准,从GMP的法律基础、机构人员设置和框架结构方面比较,从而得出完善我国GMP体系结构的启示。结果与结论:国内外均实行相似的GMP二级认证管理体系,但在法律基础和机构人员设置方面,我国GMP管理有待完善;在框架结构方面,我国2010年新修订GMP尚缺少详细完善的补充说明,对原料药、中药材GMP要求的重视程度有待提高。
Objective： To explore the differences between the system structures of GMP in China and a- broad in order to improve GMP management in our country. Methods： Based on newly revised Chinese GMP in 2010, we compared GMP standards used in EU, USA, WHO, PIC/S, Japan in legal basis, agency staff and frame structure to improve the system structure of GMP used in China. Results and Conclusion： The certified manage- ment systems of GMP both in China and abroad are similar. In aspects of the legal basis and agency staff, Chinese GMP management needs to be improved. In the frame structure, newly revised Chinese GMP in 2010 still lack de- tailed supplemental descriptions. Also we should pay more attention to GMP requirements of active pharmaceutical ingredients and Chinese herbal medicines.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第5期505-509,共5页
Chinese Journal of New Drugs
关键词
2010年新修订GMP
体系结构
比较
newly revised Chinese GMP in 2010
system structure
comparison
