药品GSP检查员培训效果影响因素分析及建议  

Influence Factors of Training Effect of Drug GSP Inspectors and Corresponding Suggestions

作　　者：张守钗 ZHANG Shouchai(Hangzhou Jianggan District Market Supervision Bureau,Hangzhou,Zhejiang,China 310016)

机构地区：[1]浙江省杭州市江干区市场监督管理局,浙江杭州310016

出　　处：《中国药业》2022年第10期42-44,共3页China Pharmaceuticals

摘　　要：目的提升《药品经营质量管理规范》(GSP)检查员培训效果。方法阐述药品GSP检查员的培训现状,分析影响培训效果的因素,并提出有针对性的建议。结果与结论目前药品GSP检查员培训体系不够健全,存在培训内容缺乏系统性、针对性,培训方式单一,师资队伍力量较薄弱,培训考核激励机制不完善等问题,均直接影响药品GSP检查员培训效果。建议结合药品GSP检查员分级分类,优化培训管理,提供内容丰富、形式多样的培训方式,辅以考核激励机制,建立模拟经营企业,开展仿真培训,从而提升培训效果。Objective To improve the training effect of drug Good Supply Practice(GSP)inspectors.Methods The training status of drug GSP inspectors was described,the factors affecting the training effect were analyzed,and targeted suggestions were put forward.Results and Conclusion At present,the training system for drug GSP inspectors is not perfect,the training content is not systematic and targeted,the training method is monotonous,the capabilities of the teacher group was weak,and the assessment and incentive mechanism of training is not perfect,which directly affect the training effect of drug GSP inspectors.It is suggested to combine the classification of drug GSP inspectors,optimize the training management,provide rich and diverse training methods,establish an assessment and incentive mechanism,construct a simulated business enterprise and carry out simulated training to improve the training effect.

关 键 词：《药品经营质量管理规范》 检查员 影响因素 培训效果 药品监管 

分 类 号：R95[医药卫生—药学]