药品经营企业现场检查常见问题分析  

Analysis of Common Problems in On-Site Inspection of Drug-Trading Enterprises

作　　者：唐红 白小琼 TANG Hong;BAI Xiaoqiong(Chongqing Drug Technology Evaluation and Certification Center,Chongqing,China 401120)

机构地区：[1]重庆市药品技术审评认证中心,重庆401120

出　　处：《中国药业》2020年第20期16-19,共4页China Pharmaceuticals

摘　　要：目的为药品经营企业在新形势下开展符合性检查,以及企业规范药品经营行为、提升管理水平、减少药品流通安全事故发生提供参考。方法统计重庆市2018年至2019年涉及整改的45家药品经营企业在现场检查中发现的缺陷项目,对出现问题项目进行汇总与分析。结果与结论共发现缺陷项目551条,包括主要缺陷项目285条(涉及26项条款)和一般缺陷项目266条(涉及118项条款),其中502条出现问题。常见问题涉及岗位职责,人员资质、培训开展及健康体检,质量管理体系及相关文件,硬件设施及验证,软件(计算机)系统,购销和售后管理,收货、验收及储存、养护,运输与配送管理等方面,梳理上述个性或共性问题,可进一步规范药品经营企业行为,为药品流通环节的合规性提供保障。Objective To analyze the defects in the on-site inspections of drug-trading enterprises,so as to provide references for relevant personnel in the compliance inspections under the new regulatory situation,and for enterprises in regulating drug-trading behaviors,improving management skills and reducing safety accidents.Methods The defective items found in the on-site inspections of 45 drug-trading enterprises in Chongqing from 2018 to 2019 were summarized and analyzed.Results and Conclusion A total of 551 defective items were found,of which 285 items were categorized in 26 articles as main defects,266 items were categorized in 118 articles as general defects,and 502 items were defective.Frequent defects involved job responsibilities,personnel qualifications,training development and health examinations,quality management systems and related documents,hardware facilities and verification,software(computer)systems,purchase and sales and after-sales management,receipt,inspection and storage,maintenance,transportation and distribution in terms of management and other aspects.Sorting out the above-mentioned individual or common defects can further standardize the behavior of drug-trading enterprises and provide guarantee for the compliance of drug circulation.

关 键 词：药品经营企业 现场检查 缺陷项目 质量风险 药品流通 药品监管 

分 类 号：R95[医药卫生—药学]