摘要
目的建立药品检查关键绩效指标(KPI)的识别模型和KPI示例,为药品检查机构制定药品检查KPI提供参考。方法对世界卫生组织(WHO)全球基准评估工具(GBT)中药品监管绩效指标(KPI)进行归纳,研究逻辑模型在KPI识别和制定中的应用。结果建立药品检查KPI的识别模型,提出药品检查KPI识别维护的8个模块,并利用该模型制定药品检查和检查能力的KPI示例。结论药品检查KPI的识别模型提供了KPI建立方法学和标准,为药品检查质量管理体系持续改进提供参考。
Objective To establish an identification model and examples of key performance indicators(KPIs)for drug inspection so as to provide references for formulating drug inspection KPIs by drug inspection institutions.Methods The drug regulatory key performance indicators(KPIs)in the Global Benchmarking Tool(GBT)of the World Health Organization(WHO)were studied,the characteristics of KPIs were summarized,the applications of logical models in the identification and formulation of KPIs were outlined.Results An identification model for drug inspection KPIs was established,eight maintenance modules for identification of drug inspection KPIs were proposed,and examples of drug inspection and inspection ability were developed with the model.Conclusion The identification model for drug inspection KPIs provides the methodology and standards for establishment of KPIs,and promotes the improvement of the quality management system(QMS)for drug inspection.
作者
宋福鱼
曹轶
SONG Fuyu;CAO Yi(Center for Food and Drug Inspection of National Medical Products Administration,Beijing 100076,China)
出处
《中国药物警戒》
2024年第12期1411-1414,共4页
Chinese Journal of Pharmacovigilance
关键词
药品检查
药品质量
药品安全
关键绩效指标
质量管理体系
全球基准评估工具
药品检查机构
检查员
Drug Inspection
Drug Quality
Drug Safety
Key Performance Indicators(KPI)
Quality Management System(QMS)
Global Benchmarking Tool(GBT)
Drug Inspection Institution
Inspector
