Current GMP in China vs. the 2008 Version GMP in European Union
- VernacularTitle:我国现行GMP与2008版欧盟GMP的异同
- Author:
Taimei CAI
- Publication Type:Journal Article
- Keywords:
China;
European Union;
GMP;
Comparison
- From:
China Pharmacy
2005;0(22):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To promote the development of GMP in China.METHODS:Based on our practice in the EU GMP-certified pharmaceutical companies,the differences between current GMP in China and the 2008 version GMP in EU was compared in aspects of personnel,workshop and equipment,GMP documentation,production management,quality control,quality management and environment,etc.RESULTS & CONCLUSIONS:There are great differences between the current GMP in China and the 2008 version GMP in EU in terms of production management and GMP software,etc.In revising GMP,we should draw experiences from EU about their advanced management ideas.
