药品上市许可持有人委托生产受托方选择质量风险管理研究  

Quality Risk Management of the Selection of Entrusted Production Enterprise by Marketing Authorization Holder

作　　者：张冉 宋明月 武志昂[1,2,3] 齐文渊 ZHANG Ran;SONG Mingyue;WU Zhi’ang;QI Wenyuan(College of Business Administration,Shenyang Pharmaceutical University,Shenyang,Liaoning,China 110016;Beijing Yeedozencom Healthcare Science&Technology Co.,Ltd.,Beging,China 100055;Shenzhen Yeehong Institute of Biomedical Development,Shenzhen,Guangdong,China 518000;Clinical Trial Center,Beijing Hospital·National Center of Gerontology·Institute of Geriatric Medicine,Chinese Academy of Medical Science·Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation,Beijing,China 100730)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016 [2]北京亦度正康健康科技有限公司,北京100055 [3]深圳市生物医药发展研究院,广东深圳518000 [4]北京医院临床试验研究中心·国家老年医学中心·中国医学科学院老年医学研究所·药物临床风险与个体化应用评价北京市重点实验室,北京100730

出　　处：《中国药业》2021年第17期1-6,共6页China Pharmaceuticals

基　　金：国家科技重大专项课题[2017zx09101001]。

摘　　要：目的建立药品上市许可持有人(MAH)委托生产受托方选择质量风险管理的一般方法。方法运用质量风险管理理论,采用失效模式、影响及危害性分析(FMECA)法,结合文献研究法、问卷调查法和专家意见法对MAH委托生产受托方选择质量进行风险评估。结果失效模式中,风险优先数(RPN)<15分的低风险失效模式0个;15分≤RPN<26分的中风险失效模式26个,包括设施与设备管理环节10个、物料管理环节5个、文件与记录管理环节6个、环境管理环节3个、MAH受托方选择自身建设环节2个;RPN≥26分的高风险失效模式37个,包括人员管理环节3个、MAH受托方选择自身建设环节7个、物料管理环节10个、文件与记录管理环节10个、设施与设备管理环节4个、环境管理环节3个。结论所建立的MAH委托生产受托方选择FMECA模型有助于明确委托生产受托方选择的改进重点,提升风险管理效果。Objective To establish a general method for quality risk management of the selection of entrusted production enterprise by marketing authorization holder(MAH).Methods Based on theory of quality risk management,the failure mode,the effects and criticality analysis(FMECA)combined with literature research,questionnaire survey and expert opinion was used to conduct the risk assessment on the quality of selection of entrusted production enterprise by MAH.Results In the failure modes,there was no low-risk failure mode with risk priority number(RPN)<15 points,there were 26 medium risk failure modes with 15 points≤RPN<26 points,including10 facilities and equipment management links,five material management links,six document and record management links,three environmental management links,two entrusted production enterprise’s self-construction links selected by MAH,and there were 37 high-risk failure modes with RPN≥26 points,including three personnel management links,seven entrusted production enterprise’s self-construction links selected by MAH,10 material management links,10 document and record management links,four facility and equipment management links and three environmental management links.Conclusion The established FMECA model for the selection of entrusted production enterprise by MAH is helpful to clarify the improvement focus of the selection of entrusted production enterprise and improve the effectiveness of risk management.

关 键 词：药品上市许可持有人 委托生产受托方 质量风险 药品监管 

分 类 号：R95[医药卫生—药学]