Objective: Under the new situation of deepening reform, the article discussed how to adapt the primary drug control institutions to the new situation of reform, improve the quality management level, and meet the new requirements of reform. Methods: By means of literature retrieval and field research, the authors collected relevant information and analyzed the current situation and problems of quality management in the primary drug control institutions under the new situation. Results and Conclusion: Primary drug control institutions should take advantage of its good tradition, strengthen quality risk control, instrument and equipment management and internal check work, and take the initiative to adapt to the new requirements of reform and development.
Chen Jiao, Hao Xiang
. Reflections on Improving the Quality Management Level of Primary Drug Control Institutions under the New Situation[J]. Chinese Pharmaceutical Affairs, 2020
, 34(3)
: 306
-310
.
DOI: 10.16153/j.1002-7777.2020.03.009
[1] 国家食品药品监督管理总局. 关于加强食品药品检验检测体系建设的指导意见[E B/O L]. (2015-01-30)[2019-07-08]. http://samr.cfda.gov.cn/WS01/CL0050/113431.html.
[2] 曾令贵,魏志刚,唐桂鹏. 药品检验机构改革发展的思考[J]. 中国药事,2019,33(2):121-125.
[3] 中国人大网. 中华人民共和国药品管理法[EB/OL]. (2019-08-26)[2019-08-27]. http://www.npc.gov.cn/npc/c30834/201908/74f80979020546948bce73160138a285.shtml.
[4] 中华人民共和国中央人民政府. 国务院关于加强质量认证体系建设促进全面质量管理的意见[EB/OL].(2018-01-26)[2019-07-08]. http://www.gov.cn/zhengce/content/2018-01/26/content_5260858.htm.
[5] 国家药品监督管理局. 中国国家药品监督管理局当选为国际人用药品注册技术协调会管理委员会成员[EB/OL].(2018-06-07)[2019-07-08]. http://www.nmpa.gov.cn/WS04/CL2056/228304.html.
[6] 药智网. ICH指导原则[EB/OL].(2017-02-15)[2019-07-08]. https://bbs.yaozh.com/thread-266062-1-1.html.
[7] 成晓英. 食品卫生管理检验体系风险防控初探[J]. 中国药物与临床,2018,18(7):1239-1240.
[8] 许立君,马晓彬,马鹏飞. 基层食品药品检验机构大型仪器设备管理关键环节控制的探讨[J]. 中国卫生产业,2017,23:181-182.
[9] 熊茜. 检验检测机构实验室内部审核工作探析[J]. 中国检验检测,2018,5:46-47.
[10] 彭晶,杨惠成. 浅谈检验检测机构监督抽检的关键风险点控制[J]. 轻工科技,2019,6:117-118.
[11] 邹皓,林涛,韩蒙,等. 特种设备检验检测机构全面质量管理体系的构建[J]. 中国特种设备安全,2019, (1):45-49.
[12] 何远,陈云,王适群,等."互联网+"时代大型仪器设备共享平台管理效率及服务能力的提升[J]. 实验科学与技术,2016,(10):208-211.
