单体药店两轮GSP认证检查缺陷项目比较分析

Comparative Analysis of Defects in Two Rounds of GSP Certification Inspection of Single Drugstores

目的:提升单体药店GSP实施效率,进一步提高质量管理水平,确保公众用药安全。方法:比较分析杭州市江干区单体药店两轮GSP认证现场检查缺陷项目,找出GSP执行中存在的问题并分析原因,提出建议及对策。结果:第二轮认证检查在条款项数、整改率及平均缺陷项频次较第一轮都有所下降;两轮认证检查缺陷项目主要集中在文件、人员及陈列与存储环节;^(*)13501、15101、13101及16704是两轮认证检查均易出现的高频次缺陷项目;^(*)16101在第二轮出现频次较第一轮上升明显;^(*)16106和16601是第二轮新出现的高频次缺陷项目。结论:应从企业、监管部门及行业角度多管齐下,加强企业自身建设,督促落实企业主体责任;加强认证后监管;发挥行业支撑作用,确保GSP有效实施。

Objective:To provide references for the effective implementation of GSP in single drugstores and further quality management level,to ensure the public drug safety.Methods:Through the comparative analysis of defects in two rounds of GSP certification inspection of single drugstores,the problems in GSP implementation were found,the reasons were analyzed,suggestions and countermeasures were proposed.Results:The number of items,rectification rate and average frequency of defects in the second round of certification inspection are lower than those in the first round.The defects in the two rounds of certification inspection mainly focused on documents,personnel,display and storage.^(*)13501,15101,13101 and 16704 are the high-frequency defects in the two rounds of certification inspections.The frequency of^(*)16101 in the second round is higher than that in the first round.^(*)16106 and 16601 are new high frequency defects in the second round of certification.Conclusion:The enterprises,regulatory authorities and the industry should work together to strengthen the self-construction of enterprises,supervise the implementation of the main responsibility of enterprises,strengthen post-certification supervision,and ensure the effective implementation of GSP.