山东省新修订药品GMP认证检查情况分析  

Analysis on the instance of revised drug GMP certification inspection for Shandong Province

作　　者：韩莹[1] 柏建学[1] 

机构地区：[1]山东省药品审评认证中心,山东济南250013

出　　处：《药学研究》2013年第7期422-424,共3页Journal of Pharmaceutical Research

摘　　要：药品GMP(2010年修订)对药品生产质量管理提出了更加科学、更加全面的要求。自2011年3月1日发布实施以来,药品生产企业投入了大量的资金和精力,完善软、硬件系统,提升质量管理水平。我省自2011年6月启动新修订药品GMP认证检查,从检查情况看,企业尚存在部分问题。本次调研旨在通过对新修订药品GMP检查缺陷项目的调查、分析,发现企业实施新修订药品GMP过程中存在的主要共性问题,为今后制定有针对性的监管措施和全面推进药品GMP的实施提供技术参考。The drug GMP（2010 revision）put forward a more scientific, more comprehensive requirements for quality control of pharmaceutical production. Since the implementation in March 1st, 2011, pharmaceutical production enterprises invested a lot of money and energy, improve the software and hardware system, enhance the quality of management level. Our province start a new revised drug GMP certification examination since June 2011, the enterprise has part of the problem from the inspection situation. This research aims to survey, analysis of the new revised drug GMP inspection defects, found that the main problems of new revised drug GMP implementation in enterprises ,for the future development of targeted regulatory measures and promote the implementation of GMP provide technical reference.

关 键 词：药品 GMP认证 2010年修订 缺陷项目 

分 类 号：R951[医药卫生—药学]