目的:分析河南省药品批发企业实施新版《药品经营质量管理规范》(GSP)后跟踪检查中发现的共性问题,为今后制定有针对性的监管措施和企业避免出现类似问题提供参考。方法:对224家药品批发企业实施新版《药品经营质量管理规范》后跟踪检查中发现的缺陷项目进行统计,分析药品批发企业GSP质量体系存在的主要问题和原因,提出相应的解决措施。结果与结论:河南省药品批发企业在药品储存与养护、设施与设备、收货与验收、采购、人员与培训等方面还存在不足,企业应当持续不断地改进和完善质量管理体系;提高培训的针对性和实效性。
Objective: To analyze common problems discovered during the follow-up inspections of drug wholesale enterprises of Henan Province after 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 224 drug wholesale enterprises after the implementation of the new edition of GSP 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: There were still some deficiencies in the following aspects in the drug wholesale enterprises of Henan Province:drug storage and maintenance, facilities and equipment, receiving and acceptance, procurement, as well as personnel and training. The drug wholesale enterprises should continuously improve and perfect quality management system and make training more specific and effective.
[1] 卫生部.中华人民共和国卫生部令90号药品经营质量管理规范[S]. 2013.
[2] 韩莹,许丹. 2013年山东省新修订药品GMP认证检查情况分析[J]. 药学研究,2014,33(2):121-124.
[3] 赵汝成. F大药房门店营业人员胜任力模型的构建[J]. 中国药事,2015,29(6):595-604.
[4] 郭彦宏. 浅谈人力资源管理中胜任素质问题及对策[J]. 东方企业文化,2014,24:6-8.
[5] 陈洪忠,冉大强,林晓明,等. 山东省新修订药品GSP认证检查缺陷项目分析[J]. 中国药事,2015,29(5):462-465.
[6] 徐大兵,陈俊,崔菊霞,等. 药品生产企业质量管理体系的合理设置[J]. 中国药事,2014,28(7):732-734.
[7] 吴生齐,邹毅,孙京林,等. 药品生产企业质量保证系统运行情况调研[J]. 中国药事,2014,28(9):945-949.
[8] 杨菲,邵蓉. 欧盟药品质量规制体系对我国的启示[J]. 上海医药,2013,34(11):54-57.
[9] 张惠,黄世福,魏骅. 安徽省药品经营企业实施新修订GSP的思考[J]. 安徽医药,2013,17(12):2183-2185.
[10] 李英丽,齐文波. 药品经营企业质量管理方面的几点建议[J]. 中国医药导报,2010,7(13):163-164.
[11] 莫文娟,许辉,马娟.关于构建符合新版药品GMP要求的药品安全风险防控体系探讨[J].中国药事,2015,29(2):132-135.
[12] 国家食品药品监督管理总局食品药品审核查验中心, 国家食品药品监督管理总局高级研修学院编. 药品经营管理规范现场检查指南(批发篇)[M]. 北京:中国人口出版社,2015:10-11.
[13] 朱存节,韩文学. 药品经营企业做好销售客户资质审核工作的探讨[J]. 中国药事,2015,29(1):20-21.
[14] 周静,邵蓉,董作军. 浙江省药品安全监管政策法规体系建设状况研究[J].中国药事,2015,29(3):237-242.
[15] 王永红. 浅议如何做好当前的药品安全监管工作[J]. 中国药事,2008,22(2):93-95.