新《药品管理法》实施后河北省药品经营许可证换证检查中发现的问题分析及应对措施

Problems in Drug Distributing License Renewal Inspection in Hebei Province Under the Newly Revised Drug Administration Law and the Corresponding Measures

目的:分析新《药品管理法》实施后河北省药品经营许可证换证检查过程中发现的问题,提出应对措施,为药品监管部门检查及药品经营企业完善药品经营质量管理提供参考。方法:对2020年河北省276家次药品批发企业现场检查中发现的缺陷项目进行统计,分析企业在药品经营质量管理中存在的问题,提出相应的解决措施和建议。结果与结论:现场检查共发现3259条缺陷项,主要集中在储存与养护(20.59%)、设施与设备(19.48%)、人员与培训(14.02%)、收货与验收(8.75%)、质量管理体系(7.52%)、质量管理体系文件(7.18%)6个方面。企业应重视管理药品质量风险,突出企业为药品质量责任主体,确保药品质量。监管部门要深入贯彻实施新《药品管理法》,积极打造专业化、高素质的检查员队伍,督促企业经营全过程持续符合法定要求。

Objective:To provide reference for drug regulatory inspection and improvement of quality management of drug distributing enterprises by analyzing the problems found in the process of drug distributing license renewal inspection in Hebei Province after the implementation of the newly revised Drug Administration Law,and proposing response measures.Methods:The defective items found in 276 on-site inspection reports of pharmaceutical whole sale enterprises in Hebei province in 2020 were counted,the problems existing in the quality management were analyzed,and corresponding measures and suggestions were put forward.Results and Conclusion:3259 defective items were found during the on-site inspections.The defective items were mainly focused on six aspects:storage and maintenance(20.59%),facilities and equipment(19.48%),personnel and training(14.02%),acceptance and inspection of goods(8.75%),quality management systems(7.52%),and quality management system documents(7.18%).Enterprises should pay attention to the management of drug quality risks,recoginizing that enterprises are the main body of drug quality responsibility,to ensure the drug quality,to achieve long-term development of enterprises.The regulatory authorities should combine the in-depth implementation of newly revised Drug Administration Law,actively build a professional,high-quality team of inspectors,and urge enterprises to continue to meet the legal requirements throughout the process.