Objective: To analyze the situation and common problems discovered between 2018 and 2019 during the follow-up inspections of drug wholesale enterprises of Guangdong Province as the new Good Supply Practice (GSP) was implemented with the aim to provide references for making regulatory measures and avoiding similar problems. Methods: The defective items found during the follow-up inspections of 122 drug wholesale enterprises were analyzed. The main problems and possible causes in quality management system of the drug wholesale enterprises were also analyzed and the corresponding countermeasures were put forward. Results and Conclusion: In the GSP follow-up inspections of 122 drug wholesale enterprises, a total of 141 items, equal to 488 defective items were found, which were mainly distributed in five aspects, including drug storage and maintenance(18.03%), facilities and equipment(14.75%), personnel and training(13.93%), institutional and quality management responsibilities(7.58%), as well as quality management system(7.17%). The drug wholesale enterprises should improve the pertinence and effectiveness of the training, enhance quality management system internal verification, give full play to the role of the quality management department in all aspects and continuously improve and perfect quality management system.
Key words
Good Supply Practice;follow-up inspection;defective items;analysis
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References
[1] 国家食品药品监督管理总局. 国家食品药品监督管理总局令第28号[S]. 2016.
[2] 刘华,魏莉,刘卫平,等. 河北省药品批发企业GSP认证检查缺陷项目分析[J]. 世界最新医学信息文摘, 2019,19(76):303-304.
[3] 王兰. 浅谈如何持续强化药品经营企业GSP认证后的质量管理工作[J]. 临床医药文献电子杂志,2019,6(67):184-185.
[4] 国家食品药品监督管理总局. 国家食品药品监督管理总局关于整治药品流通领域违法经营行为的公告第94号[S]. 2016.
[5] 王炜佳. 黑龙江省药品经营企业(批发)GSP认证检查缺陷项分析[J]. 黑龙江医药,2017,30(3):530-534.
[6] 韦忠喜. 如何持续强化药品经营企业GSP认证后的质量管理工作[J]. 中国药物滥用防治杂志,2018,24(3):169-171.
[7] 宋秀君. 药品批发企业药品储存养护的探讨[J]. 世界最新医学信息文摘,2018,18(A5):47-49.
[8] 张少兰. 药品经营企业GSP实施中质量管理体系内审的应用与实践[J]. 中国药业,2017,26(2):85-88.
[9] 杨爱民,向勇. 药品经营企业如何应用GSP开展质量管理体系评审[J]. 首都医药,2010,17(16):30-32.
[10] 罗晓媚,彭启星,侯珺. 广州市药品零售企业新版GSP认证跟踪检查情况分析[J]. 今日药学,2017,27(11):752-756.
[11] 康健. 药品经营企业如何建立完善的质量管理体系[J]. 中国卫生产业,2016,13(8):21-23.
[12] 湖北省食品药品监督管理局药化流通处. 湖北省将开展药品批发企业GSP跟踪检查切实加强事中事后监管[J]. 医药导报,2015,(5):588.
[13] 段伦霞. 浅谈药品批发企业GSP认证跟踪检查结果的统计分析与对策[J]. 临床医药文献电子杂志,2018,5(58):181-182.
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