我国2010年修订GMP与国外典型GMP实施内容的比较研究  

Comparison of implementation contents in the new revised Chinese GMP in 2010 and foreign typical GMPs

作　　者：颜建周[1] 李玲[1] 邵蓉[1] 

机构地区：[1]中国药科大学国家药物政策与医药产业经济研究中心,南京211198

出　　处：《中国新药杂志》2015年第19期2179-2182,共4页Chinese Journal of New Drugs

基　　金：国家社会科学基金一般项目<药品质量规制视角下的药品监管法实施效果研究>(11BFX098);中国药科大学医药产业发展研究中心社会科学研究基金(CPUSJ1308)

摘　　要：对我国2010年修订的《药品生产质量管理规范》(Good Manufacturing Practices of Drugs,GMP)与国外典型GMP在具体条款和实施过程中存在的差异进行深入剖析,为我国制药企业的国际化发展提供参考。结合世界卫生组织(World Health Organization,WHO)、国际药品认证合作组织(Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme,PIC/S)的GMP规范,将欧盟、美国、日本GMP标准与我国2010年GMP重点修订内容进行对比。通过对比发现,我国GMP中质量受权人制度有待完善,无菌药品生产要求细微方面稍低于欧盟GMP标准,实验室检验还需重视超常检验结果(Out of Trend,OOT)的调查,参数放行理念亟待推广。The differences in the implementation contents of Good Manufacturing Practices of Drugs（ GMP）at home and abroad were analyzed in order to improve GMP management in our country. Based on the newly revised Chinese GMP in 2010,we compared it with GMP standards used in EU,USA,World Health Organization（ WHO）,Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme（ PIC/S） and Japan in the key amendments. We found that the quality system of authorized person,sterile drug production requirements were slightly below the EU GMP standard,and Out of Trend（ OOT） results of laboratory tests should be paid more attention. The concept of parametric release also should be promoted.

关 键 词：2010年修订GMP 实施内容 比较 

分 类 号：R95[医药卫生—药学]