药械妆企业质量信用评价指标体系的构建  

Construction of an Evaluation Indicator System for the Quality Credit of Pharmaceutical,Medical Device,and Cosmetic Enterprises

作　　者：漆亮 宋宇 洪玲洁 郭文琼 夏雪琴 QI Liang;SONG Yu;HONG Ling-jie;GUO Wen-qiong;XIA Xue-qin(Jiangxi Center for Drug Certification and Evaluation)

机构地区：[1]江西省药品认证审评中心

出　　处：《中国食品药品监管》2024年第8期126-137,共12页China Food & Drug Administration Magazine

基　　金：江西省科技计划项目(20112BBE50023);江西省药品监督管理局科研项目(2021KY16)。

摘　　要：目的:通过分析药械妆企业质量信用特征,构建药械妆企业质量信用评价指标体系,科学监测药械妆企业风险,进一步提升监管效能。方法:分析筛选药械妆企业质量信用特征因素,采用德尔菲法确立评价指标,使用序关系分析法确定指标权重,采用模糊综合评价法得出药械妆企业质量信用等级。结果与结论:建立了基于序关系分析法的药械妆企业质量信用评价指标体系,并随机选取企业进行实证研究,评价结果与现场检查结论相符,表明所构建的药械妆企业质量信用评价指标体系具有良好的实用性。Objective:This study aims to analyze the quality credit characteristics of pharmaceutical,medical device,and cosmetic enterprises and to construct an evaluation indicator system to monitor their risks more scientifically and further improve regulatory efficiency.Methods:The factors influencing the quality credit of these enterprises quality credit were analyzed and selected.The initial evaluation indicators were construed using the Delphi method.Subsequently,the weight of each indicator was determined using the order relation analysis method.Finally,the quality credit level was assessed using the fuzzy comprehensive evaluation method.Results and Conclusion:An evaluation indicator system based on the order relation analysis method for the quality credit of pharmaceutical,medical device,and cosmetic enterprises was established.Empirical research was conducted by randomly selecting enterprises.The evaluation results are consistent with on-site inspection conclusions,indicating that the evaluation indicator system for the quality credit of these enterprises has good practicability.

关 键 词：药品监管 质量信用 评价指标体系 序关系分析法 模糊综合评价法 

分 类 号：R95[医药卫生—药学]