2015年山东省药品GMP认证检查情况分析  

Analysis on the situation of drug GMP certification inspection for Shandong Province in 2015

作　　者：韩莹[1] 柏建学[1] 许丹[1] 曹鸿雁[1] 胡敬峰 柴发永[1] 

机构地区：[1]山东省食品药品监督管理局审评认证中心,山东济南250014

出　　处：《药学研究》2016年第7期427-430,共4页Journal of Pharmaceutical Research

摘　　要：《药品生产质量管理规范(2010年修订)》已颁布实施5年,但从2015年度认证检查情况看,部分企业的生产质量管理仍存在薄弱环节。本文通过对2015年度的检查缺陷项目的汇总分析,并与2014年度的检查情况进行对比,供业内掌握药品生产企业仍存在的突出问题;同时提出改进建议。Good Manufacturing Practice（ Revised 2010）had been formally promulgated and implemented for five years. However,there were still various weakness for certain pharmaceutical enterprises in the production quality manage-ment from the analysis on the situation of the certification inspection in 2015. This paper aimed to discover the outstanding problems existing in pharmaceutical production enterprises for the industry through the comparative analysis of the annual inspection defect items in 2015 and 2014. At the same time,this paper also provided improvement suggestion for pharmaceu-tical enterprises.

关 键 词：GMP 认证 缺陷项目 分析 建议 

分 类 号：R95[医药卫生—药学]