职业化药品生产检查员胜任力评价指标体系研究  

Competence Evaluation Index System for Professional Good Manufacturing Practice Inspectors

作　　者：张琪 周军红 杨彦坤 杨斌 潘晶 王丹 ZHANG Qi;ZHOU Junhong;YANG Yankun;YANG Bin;PAN Jing;WANG Dan(Shaanxi Center for Drug and Vaccine Inspection,Xi′an,Shaanxi,China 710065)

机构地区：[1]陕西省药品和疫苗检查中心,陕西西安710065

出　　处：《中国药业》2022年第21期7-10,共4页China Pharmaceuticals

基　　金：陕西省药品科学监管和监管科学研究项目[SXYJ202103]。

摘　　要：目的建立科学的药品生产检查员胜任力评价指标体系。方法运用文献调研法和德尔菲专家咨询法确定药品生产检查员胜任力评价二维指标;从管理、人事、药品生产监管、药品生产检查、药品生产企业等多领域遴选16位咨询专家,运用改进群组层次分析(AHP)法计算指标权重和专家权重,对专家权重和指标权重进行加权平均,综合得出最终指标权重。结果建立了按权重分配的4个一级指标、16个二级指标的药品生产检查员胜任力评价指标体系。结论所构建的药品生产检查员胜任力评价指标体系科学、全面、客观,可为药品生产检查员的选拔、准入、升降、考核等提供评估工具。Objective To establish a scientific competence evaluation index system for good manufacturing practice(GMP)inspectors.Methods The two-dimensional indexes of the competency evaluation for the GMP inspectors were determined by the studies and Delphi expert consultation method.Sixteen consulting experts were selected from the management,personnel,drug production administration,drug production inspection,phamaceutical manufactures and other fields.The weight of the indexes and the weight of experts′opinions were calculated by the improved group analytic hierarchy process(AHP)method,and the weighted average of the above weights was used to obtain the weight of final index.Results A competency evaluation index system for GMP inspectors was established with four grade indexes and 16 secondary indexes allocated according to the weight.Conclusion The established competency evaluation index system for GMP inspectors is scientific,comprehensive and objective,which can provide an evaluation tool for the selection,admission,promotion,demotion and assessment of GMP inspectors.

关 键 词：药品生产检查员 胜任力评价指标体系 改进群组层次分析法 药品监管 

分 类 号：R95[医药卫生—药学]