药品质量风险监测工作机制建设态势分析  

Situation analysis of drug quality risk monitoring working mechanism construction

作　　者：周维利 赵艳霞 孙铜 王坤 华逢彪 宗凤玉 程春雷 ZHOU Weili;ZHAO Yanxia;SUN Tong;WANG Kun;HUA Fengbiao;ZONG Fengyu;CHENG Chunlei(Shandong Institute of Food and Drug Control,Jinan 250101,China;Shandong Provincial Drug Administration,Jinan 250014,China)

机构地区：[1]山东省食品药品检验研究院,山东济南250101 [2]山东省药品监督管理局,山东济南250014

出　　处：《药学研究》2022年第11期767-770,共4页Journal of Pharmaceutical Research

摘　　要：目的分析山东省药品质量风险监测工作建设面临的态势,为进一步提高药品质量管理水平提供参考。方法梳理分析我省药品质量风险监测工作情况及采取的措施,参考道斯矩阵(SWOT)进行分析药品质量风险监测工作机制建设的优势、劣势、机会和挑战。结果与结论药品质量风险监测工作,作为常规抽检的重要补充,发挥了药品监督及服务企业的作用,同时面临着内部和外部的有利与不利因素,建议充分利用网络智慧监管、优化抽检工作安排、加强业务培训、培养专家队伍、完善信息公开、注重日常监管,对药品质量风险监测工作机制不断完善,全面提升药品监管效能。Objective To analyze the situation of drug quality risk monitoring in Shandong Province,provide reference for further improving drug quality management.Methods The work situation and measures of drug quality risk monitoring in our province were analyzed,and the advantages,disadvantages,opportunities and challenges of the work mechanism construction of drug quality risk monitoring were analyzed by referring to SWOT.Results and Conclusion Risk of drug quality monitoring work,as the important supplement of the conventional sampling inspection,give play to the role of the drug supervision and service enterprises,at the same time facing the favorable and unfavorable factors,the internal and external advice make full use of network intelligent supervision,optimizing the sampling work arrangements,strengthen business training,training expertise,perfecting the information disclosure,and pay attention to daily regulation,We will constantly improve the working mechanism of drug quality risk monitoring,and comprehensively improve the effectiveness of drug supervision.

关 键 词：药品质量 风险监测 工作机制建设 道斯矩阵 

分 类 号：R95[医药卫生—药学]