国家药品抽检质量风险排查处置机制关键控制点分析  

Critical Control Points Analysis of Inspection and Disposal Mechanism of the Risk in Quality of National Drug Sampling and Testing

作　　者：刘文[1] 王翀[1] 冯磊[1] 朱炯[1] 胡增峣 LIU Wen;WANG Chong;FENG Lei;ZHU Jiong;HU Zengyao(National Institutes for Food and Drug Control,Beijing,China 102629;National Medical Products Administration,Beijing,China 100037)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药品监督管理局,北京100037

出　　处：《中国药业》2022年第6期13-15,共3页China Pharmaceuticals

摘　　要：目的为完善国家药品抽检质量风险排查处置机制提供参考。方法梳理国家药品抽检中药品质量风险排查处置机制的基本情况和存在的问题,采用危害分析和关键控制点法分析存在问题的关键控制点,并提出建议。结果现行药品质量风险排查处置机制以国家药品抽检探索性研究结果为线索,对涉事生产企业开展现场检查和处置,在运行中取得了良好的监管成效。但该机制存在探索性研究的科学性和靶向性不足,风险排查处置力度不够等问题。结论相关部门应加强业务建设、优化任务分配、加强督导考核,并借鉴国外先进经验,进一步完善药品质量风险排查处置机制。Objective To provide a reference for improving inspection and disposal mechanism of the risk in quality of national drug sampling and testing.Methods The basic situation and problems of inspection and disposal mechanism of the risk in quality of national drug sampling and testing were sorted out,and critical control points with some problems were analyzed by hazard analysis and critical control point(HACCP)method,suggestions of which were put forward as well.Results Based on the results of national drug sampling and testing exploratory research,the inspection and disposal mechanism of the risk in drug quality carried out on-site inspection and disposal of the involved production enterprises,which achieved a good regulatory effectiveness.But the scientific,targeting of exploratory of research,power for risk inspection and disposal in mechanism were insufficient.Conclusion Relevant departments should strengthen business construction,supervision and assessment,optimize task allocation,improve the drug quality risk inspection and disposal mechanism based on advanced foreign experience.

关 键 词：国家药品抽检 质量风险 危害分析和关键控制点法 处置机制 

分 类 号：R95[医药卫生—药学]