Objective: To analyze some common problems found in the process of drug GSP renewal inspection in Fujian Province, and to put forward suggestions and countermeasures to promote the scientific and effective supervision of regulatory departments and push enterprises to improve the drug quality management systems. Methods: The defect items found in the renewal inspection of 321 pharmaceutical wholesalers and retail chain headquarters were statistically summarized, and the common problems existed in the enterprises were analyzed. Results and Conclusion: In the process of GSP implementation, all post personnel should participate, the awareness of responsibility and risk should be increased, and the regulations should be strictly followed. The supervision departments should cultivate a team of high-quality inspectors, strengthen the publicity and daily supervision of the newly revised GSP, and promote the standardized operation of enterprises.
Zhang Lei, Zhang Xiuhong, Wu Zhengshan, Huang Rongzhen
. Analysis of Defective Items in Drug GSP Renewal Inspection in Fujian Province[J]. Chinese Pharmaceutical Affairs, 2021
, 35(7)
: 745
-750
.
DOI: 10.16153/j.1002-7777.2021.07.003
[1] 卫生部.中华人民共和国卫生部令第90号药品经营质量管理规范[S].2013.
[2] 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13号药品经营质量管理规范[S].2015.
[3] 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号药品经营质量管理规范[S].2016.
[4] 国家药品监督管理局.药品经营许可证管理办法[EB/OL].(2017-11-21)[2021-02-17].https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20171121171201375.html.
[5] 国家药品监督管理局.关于贯彻执行《药品经营许可证管理办法》有关问题的通知(国食药监市[2004]152号)[EB/OL].(2004-04-29)[2021-02-17].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/200404290101012.html.
[6] 福建省药品监督管理局.省局2018年12月份业务工作情况表[EB/OL].(2019-01-14)[2021-02-17].http://yjj.scjgj.fujian.gov.cn/zwgk/tjxx/201901/t20190114_4743033.html.
[7] 福建省药品监督管理局.省局2020年12月份业务工作情况表[EB/OL].(2021-01-12)[2021-02-17].http://yjj.scjgj.fujian.gov.cn/zwgk/tjxx/202101/t20210112_5515494.html.
[8] 国家药品监督管理局.总局关于修订印发《药品经营质量管理规范现场检查指导原则》有关事宜的通知(食药监药化监[2016]160号)[EB/OL].(2016-12-16)[2021-02-17].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20161216172901610.html.
[9] 韦广辉,梁国泉.广西药品经营企业实施新版GSP的思考[J].中国药事,2015,29(7):718-720.
[10] 国家药品监督管理局职能配置、内设机构和人员编制规定[N].中国医药报,2018-09-12(002).
[11] 国务院办公厅.国务院办公厅关于建立职业化专业化药品检查员队伍的意见(国办发〔2019〕36号)[EB/OL].(2019-07-18)[2021-02-17].http://www.gov.cn/zhengce/content/2019-07/18/content_5411172.html.
[12] 江苏省人民政府办公厅.江苏省政府办公厅关于建立省级职业化专业化药品检查员队伍的实施意见(苏政办发〔2020〕34号)[EB/OL].(2020-05-15)[2021-02-17].http://www.jiangsu.gov.cn/art/2020/5/22/art_46144_9156202.html.
[13] 江西省人民政府办公厅.江西省人民政府办公厅关于建立职业化专业化药品检查员队伍的实施意见(赣府厅发〔2020〕38号)[EB/OL].(2020-12-07)[2021-02-17].http://www.jiangxi.gov.cn/art/2020/12/17/art_4975_2975891.html.
[14] 山东省人民政府办公厅.山东省人民政府办公厅关于建立省级职业化专业化药品检查员队伍的实施意见(鲁政办发〔2020〕21号)[EB/OL].(2020-11-23)[2021-02-17].http://www.shandong.gov.cn/art/2020/11/23/art_107861_109436.html.
[15] 陈海娟,张江清,郝晓雯,等.省级食品药品检查员队伍建设困境与破解路径初探[J].中国食品药品监管,2021,(2):80-86.
[16] 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.
