安徽省药品批发企业两轮《药品经营质量管理规范》认证检查情况比较

Comparison of Two Rounds of Good Supply Practice Certification Inspection of Pharmaceutical Wholesale Enterprises in Anhui Province

目的总结安徽省药品批发企业新修订《药品经营质量管理规范》首次认证和5年换证检查情况,为促进其规范经营和加强有效监管提供参考。方法汇总并比较安徽省药品批发企业2013年至2015年(第一轮认证)447家和2018年至2019年(第二轮换证)271家检查情况,分析异同点,并提出建议。结果现场检查一次性通过率提高了32.69%;第一轮认证共发现主要缺陷项目1039频次,一般缺陷项目4489频次;第二轮换证共发现主要缺陷项目175频次,一般缺陷项目1731频次。缺陷项主要集中在质量管理体系、验证校准、计算机系统等方面。结论建议强化企业主体责任,增强全员质量意识,多途径开展针对性培训,加强检查员能力建设,严控质量风险。

Objective To summarize the situation of the newly revised Good Supply Practice(GSP)for the first time and the five-year renewal inspection of pharmaceutical wholesale enterprises in Anhui province,and to provide a reference for promoting the standardized operation and strengthening the effective supervision of the wholesales.Methods The inspection status of 447 newly revised GSP wholesalers certified for the first time from 2013 to 2015(the first round of certification)and 271 wholesalers re-certified from2018 to 2019(the second round of re-certification)in Anhui province were summarized and compared to analyze relevant similarities and differences and put forward suggestions.Results The one-time pass rate of on-site inspection increased by 32.69%.In the first round of certification,major defect items were found 1039 times and general defect items were found 4489 times.In the second round of re-certification,major defect items were found 175 times and general defect items were found 1731 times.The defect items mainly focused on quality management system,verification and calibration,computer system and so on.Conclusion It is suggested to strengthen the main responsibility of the pharmaceutical wholesale enterprises and enhance the quality consciousness of all employees,carry out targeted training in multiple ways,strengthen the capacity building of inspectors,and strictly control the quality risk.