我国现行GMP与2008版欧盟GMP的异同

目的:促进我国《药品生产质量管理规范》(GMP)的发展。方法:结合通过欧盟GMP认证制药企业的实践,对我国现行GMP与2008版欧盟GMP从人员、厂房及设施、GMP文件、生产管理、质量控制和质量管理、环境等方面的异同进行比较。结果与结论:我国现行GMP与2008版欧盟GMP在生产管理及GMP软件等方面有较大的差异,我国进行GMP修订时,可借鉴欧盟GMP先进的管理理念。

Current GMP in China vs. the 2008 Version GMP in European Union

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.