中国药业2016，Vol.25Issue(14)：16-18,19,4.
云南省药品生产企业GMP认证检查缺陷项目统计分析
Stastical Analysis of GMP Certification Defective Items of Pharmaceutical Manufacturers in Yunnan Province
周玲 1谭文红2
作者信息
- 1. 云南省食品药品监督管理局药品审评中心，云南 昆明 650106
- 2. 云南中医学院，云南 昆明 650504
- 折叠
摘要
Abstract
Objective To put forward counter measures and suggestions on accelerating pharmaceutical manufacturers to implement cur-rent GMP through analyzing the current defective items of GMP on-site certification inspection. Methods 176 pharmaceutical manufac-turers which were approved by the centre or passed the unannounced inspection from 2011 to 2015 were collected and their main de-fective items were analyzed,summerized,and classified. Results and Conclusion To ensure correct and thorough implementation of the new version of GMP,we should increase training efforts,set up full- time inspector team and pay equal attention to both hardware and software.关键词
药品生产质量管理规范/认证检查/缺陷项目/药品质量管理Key words
GMP/certification inspetion/defective items/drug quality management分类
医药卫生引用本文复制引用
周玲,谭文红..云南省药品生产企业GMP认证检查缺陷项目统计分析[J].中国药业,2016,25(14):16-18,19,4.
