制药企业在2010版药品GMP实施过程中召回管理现状与常见问题分析  

The Present Situation and Analyses of Main Problems of Drug Recall Management in the Implementation Process of Drug GMP(2010 Edition)

作　　者：邹毅[1] 林秀旎[1] 吴生齐[1] 陈佩毅[1] 李志伟[1] 许维伊[1] 陈琳琳[1] 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广东广州510080

出　　处：《广东化工》2014年第17期102-102,104,共2页Guangdong Chemical Industry

基　　金：广东省软科学研究计划项目(项目编号:2012B070300037)资助

摘　　要：总结制药企业在2010版药品GMP实施过程中召回管理的现状,并分析存在问题,包括对产品召回持消极态度,召回管理方面培训不到位,操作规程缺乏可操作性,有效性评估不足等。建议制药企业必须重视产品召回的管理,严格按照2010版药品GMP的要求积极建立召回系统。The present situation of drug recall management in the implementation process of drug GMP （2010 edition） has been summed up in the article. The main problems of it have been also analyzed such as the negative attitude of pharmaceutical companies toward drug recall management, the insufficient training on drug recall management, the less practicality of standard operating procedures of drug recall management, insufficient evaluation of efficacy of drug recall management system. The authors suggest that the pharmaceutical company must pay high attention to drug recall management and build up the drug recall management system in strict accordance with drug GMP（2010 edition）.

关 键 词：2010版药品GMP 召回管理 问题 

分 类 号：TQ[化学工程]