广州市高风险药品经营企业监督检查缺陷项目分析  

Defective Items in Supervision and Inspection of High-Risk Pharmaceutical Trading Enterprises in Guangzhou

作　　者：侯珺 阎英 黄炳生 吴生齐 HOU Jun;YAN Ying;HUANG Bingsheng;WU Shengqi(Center for Certification and Evaluation,Guangzhou Food and Drug Administration,Guangzhou,Guangdong,China 510140;Center for Certification and Evaluation,Guangdong Drug Administration,Guangzhou,Guangdong,China 510080)

机构地区：[1]广东省广州市食品药品监督管理局审评认证中心,广东广州510140 [2]广东省药品监督管理局审评认证中心,广东广州510080

出　　处：《中国药业》2023年第5期32-35,共4页China Pharmaceuticals

摘　　要：目的为药品监管部门制订有针对性的药品经营企业监管措施提供参考。方法统计2021年广州市27家高风险药品经营企业在监督检查中发现的缺陷项目,分析企业在执行《药品经营质量管理规范》过程中存在的主要问题和产生原因,并提出相应对策与建议。结果27家企业累计检查项目6329项次,出现严重缺陷项目的企业有8家(29.63%)。缺陷项目共计248项次(3.92%),其中严重缺陷项目11项次(4.44%),主要缺陷项目185项次(74.60%),一般缺陷项目52项次(20.97%)。缺陷条款项次数量较多的章节为质量管理体系文件30项次(12.10%),校准与验证30项次(12.10%),储存与养护28项次(11.29%),人员与培训28项次(11.29%),设施与设备27项次(10.89%),机构和质量管理职责27项次(10.89%)。结论药品经营企业应增强合规意识,加强对质量管理工作的重视,完善质量管理体系;药品监管部门应完善监管机制,加强对药品检查员的培养;药品行业协会应充分发挥沟通协调作用。Objective To provide a reference for the drug administration departments to formulate regulatory measures accordingly for pharmaceutical trading enterprises.Methods The defective items found in the supervision and inspection of 27 high-risk pharmaceutical trading enterprises in Guangzhou in 2021 were recorded,the main problems of enterprises in the implementation of the Good Supply Practice and the causes of defective items were analyzed,and the corresponding measures and suggestions were put forward.Results A total of 6329 cases were inspected in 27 enterprises,and there were eight enterprises(29.63%)with serious defective items.There were 248 cases(3.92%)of defective items,including 11 cases(4.44%)of serious defective items,185 cases(74.60%)of major defective items and 52 cases(20.97%)of general defective items.The cases of defective clauses were more in such chapters including quality management system documents(30 cases,12.10%),calibration and verification(30cases,12.10%),storage and maintenance(28 cases,11.29%),personnel and training(28 cases,11.29%),facilities and equipment(27 cases,10.89%),organization and quality management responsibilities(27 cases,10.89%).Conclusion The pharmaceutical trading enterprises should enhance the awareness of compliance,pay more attention to quality management and improve the quality management system.The drug administration departments should perfect the regulatory mechanism,strengthen the training of drug inspectors,and the pharmaceutical industry association should give full play to the role of communication and coordination.

关 键 词：药品经营企业 高风险 监督检查 缺陷项目 广州市 

分 类 号：R95[医药卫生—药学]