上海市体外诊断试剂(药品)经营企业GSP认证缺陷项目分析

Analysis of the defects in the GSP certification of in-vitro diagnosis reagents (drugs) distributing enterprises in Shanghai

目的:通过对上海市体外诊断试剂(药品)经营企业GSP认证中发现的缺陷项目汇总分析,为全面提升企业质量管理水平和加强监管提供技术参考。方法:对本市40家次体外诊断试剂(药品)经营企业GSP认证现场检查中发现的缺陷项目进行统计,分析企业质量管理体系中存在的主要问题和原因,并提出相应的对策。结果:25家药品类体外诊断试剂经营企业中,一次通过认证检查的企业10家。缺陷条款主要集中在机构和质量管理职责、设施与设备、人员与培训、采购、收货与验收这五个方面,占总缺陷项目的55.7%。结论:企业应进一步提高自身的质量管理水平,注重质量风险评估,规范药品经营行为,保障百姓用药安全。

Objective: To provide technical reference for comprehensively improving the quality management level of enterprises and strengthening supervision by the summary analysis of the defects in the GSP certification of Shanghai in-vitro diagnosis reagents (drugs) distributing enterprises. Methods: Statistics on the defects found in on-site GSP certification inspection of 40 Shanghai in-vitro diagnosis reagents (drugs) distributing enterprises and the main problems and causes in the quality management system were analyzed and the corresponding countermeasures were proposed. Results: There were 10 companies first time passed the certification inspection among the 25 enterprises. The defect clauses were mainly involved in the five aspects such as organization and quality management responsibilities, facilities and equipment, personnel and training, procurement, receipt and acceptance, accounting for 55.7% of the total defects. Conclusion: Enterprises should further improve their own quality management level, pay attention to quality risk assessment and regulate the drug distribution practices so as to ensure the medication safety of patients.