福建省药品GSP换证检查缺陷项目分析

Analysis of Defective Items in Drug GSP Renewal Inspection in Fujian Province

目的:通过分析福建省药品GSP换证检查过程中发现的一些普遍性问题,提出建议与对策,促进监管部门科学有效监管,促进企业持续提升药品质量管理体系。方法:对321家药品批发企业和零售连锁企业总部换证检查中发现的缺陷项目进行统计汇总,分析企业存在的共性问题。结果与结论:企业在实施药品GSP的过程中,各岗位人员应全员参与,提高责任意识、风险意识,严格按照制度履职;监管部门应培养一支高素质检查员队伍,加强新修订版药品GSP的宣贯与日常监督,促进企业规范经营。

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.