广东省撤销GSP证书的药品批发企业缺陷项目分析  

Analysis of Defective Items of Drug Wholesale Enterprises with GSP Certificate Revoked in Guangdong Province

作　　者：张涛志[1] 胡永新 邵倩倩 刘伟[2] Zhang Taozhi;Hu Yongxin;Shao Qianqian;Liu Wei(Department of Pharmacy,the Second Affiliated Hospital of Zhengzhou University,Zhengzhou 450014,China;School of Pharmacy,Zhengzhou University,Zhengzhou 450005,China)

机构地区：[1]郑州大学第二附属医院药学部,郑州450014 [2]郑州大学药学院,郑州450005

出　　处：《中国药事》2021年第10期1116-1122,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:为药品批发企业科学有效实施GSP、监管部门制定有针对性的监管措施提供参考。方法:对2017-2019年在国家和广东省药监部门官方网站上查询到的广东省76家被撤销GSP证书的药品批发企业在现场检查中发现的缺陷项目进行统计,分析其存在的问题,并提出相应的解决措施和建议。结果与结论:广东省被撤证药品批发企业严重缺陷项目主要集中在总则和销售部分;主要缺陷项目主要集中在储存与养护、机构和质量管理职责、人员与培训以及质量管理体系等部分。药品批发企业应强化企业质量安全第一责任人意识,提高仓库管理水平和对员工进行针对性的培训,优化质量管理体系,为企业持续长远发展提供坚实的质量保障。监管部门要加强法规宣传与监管,加大惩治力度,降低药品流通领域的质量风险。Objective: To provide references for the scientific and effective implementation of GSP in drug wholesale enterprises and the development of targeted regulatory measures by regulatory authorities. Methods:The defective items were found in the on-site inspection of 76 drug wholesale enterprises whose GSP certificates have been revoked in Guangdong Province, which were found on the official websites of the state and Guangdong Provincial Drug Administration from 2017 to 2019, the existing problems were analyzed, and the corresponding solutions and suggestions were put forward. Results and Conclusion: The seriously defective items of drug wholesale enterprises in Guangdong Province mainly focused on the general principles and sales chapters;the major defective items were mainly concentrated in the chapters of storage and maintenance, institution and quality management responsibilities, personnel and training, and quality management system. Drug wholesale enterprises should strengthen the awareness of the first responsible person for quality and safety, improve warehouse management level and targeted training for employees, optimize the quality management system, and provide solid quality guarantee for the sustainable and long-term development of enterprises. The regulatory department should strengthen the publicity and supervision of laws and regulations, increase the punishment, and reduce the quality risk in the field of drug circulation.

关 键 词：药品批发企业 撤证 药品经营质量管理规范 缺陷项目 现场检查 分析 

分 类 号：R95[医药卫生—药学]