制药企业2010版药品GMP培训分析与建议  

Deficiencies of GMP(2010 edition) Training in Pharmaceutical Companies and Advices for Pharmaceutical Companies

作　　者：邹毅[1] 饶翠芬 吴生齐[1] 陈佩毅[1] 杨永明[1] 李志伟[1] 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广州510080

出　　处：《药学教育》2014年第3期53-56,共4页Pharmaceutical Education

基　　金：广东省促进科技服务业发展计划;编号2012B040304011

摘　　要：2010版药品GMP开始实施已有3年时间,但是部分制药企业仍难以达到2010版药品GMP要求。究其原因,很大程度上是因为人员培训方面存在的问题,包括对培训缺乏积极性、培训师资力量薄弱、培训内容不够全面和深入、针对性不强、实践培训较少、培训效果评价不足。针对制药企业2010版药品GMP培训存在的问题,建议采取以下措施:高校应加强学生GMP知识培训,重视员工培训,完善培训师资,增加培训的广度与深度,加强针对性培训,强化实践培训,加强培训效果评价。The GMP（2010 edition）has been put into effect for about three years, but some pharmaceutical companies still don＇t have the ability to achieve the required standards of the GMP（2010 edition）. The key reason is that there are many deficiencies of GMP（2010 edition）training in pharmaceutical companies, such as the lack of motivation to training, the un-proficient training teachers, the insufficient breadth and depth of content for GMP training, the absence of pertinency, the less training practice, the shortage of appraisal of training. Aimed at above problems, many advices are given such as more GMP training given to the students in the university, more attention of the pharmaceutical companies to the training, the highly competent GMP training teachers, enough breadth and depth of content for GMP training, the pertinent training to specific position and person, the positive reinforcement in training practice, enough evaluation of training effectiveness.

关 键 词：2010版药品GMP 培训 制药企业 GMP论证 

分 类 号：R-4[医药卫生]