辽宁省药品GMP认证检查缺陷情况分析  

On Defective Items According to 2010 Edition GMP Certification in Liaoning Province

作　　者：王璐 赵红菊 马辉 王晓 

机构地区：[1]辽宁省药品认证中心,沈阳110016

出　　处：《中国药事》2017年第5期520-523,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:对本省GMP认证检查过程中发现的缺陷项目进行汇总、分析,为推进我省药企管理水平提供参考。方法:对本省2011年6月-2015年12月认证的225家次企业的缺陷项目进行汇总,对主要问题进行归纳、分析。结果与结论:企业应在质量管理体系、人员培训、验证管理和文件管理等方面规范各项质量管理活动,有效控制产品潜在的风险。Objective： To summarize and analyze the defects in the certification process in Liaoning Province, so as to provide technical referencess for the promotion of the implementation of GMP in pharmaceutical enterprises. Methods： The defective items of 225 manufacturers certified from June 2011 to December 2015 were reviewed, and the main problems were classified and analyzed. Results and Conclusion： The manufacturers should standardize each pharmaceutical production according to GMP with more effort on quality management system, personnel training, validation management and document management, so as to reduce the potential risk of products more effectively.

关 键 词：药品 药品生产质量管理规范 GMP认证 缺陷项目 

分 类 号：R95[医药卫生—药学] R954.2