2022年安徽省无菌药品生产企业监督检查发现的问题及建议

Problems and Suggestions in the Supervision and Inspection of Aseptic Drug Production Enterprises in Anhui Province in 2022

目的为无菌药品生产企业提高生产质量管理和药品生产监管提供参考。方法对2022年安徽省40家无菌药品生产企业监督检查发现的缺陷项目汇总分析。结果40家无菌药品生产企业缺陷项目中,质量控制与质量保证、文件管理、无菌药品附录存在的缺陷最多,占总缺陷项目比例分别为29.69%、13.20%、12.78%。严重缺陷仅1家企业,确认与验证占主要缺陷比例较高。结论企业应主动提升无菌药品生产和质量管理水平;监管部门应统一检查尺度,基于风险,个性化检查,科学监管,助力企业发展,切实维护人民群众的用药安全。

OBJECTIVE To provide reference for aseptic drug production ente rprises to improve production quality management and drug production supervision.METHODS Summarize and analyze the defects found in the superv ision and inspection of 40 sterile drug production enterprises in Anhui Province in 2022.RESULTS Among the 40 sterile drug production enterpri ses with defect projects,quality control and assurance,document management,an d sterile drug appendices had the most defects,accounting for 29.69%,13.20%,and 12.78%of the total defect projects,respectively.There is only one ente rprise with serious defects,and confirmation and verification account for a hig h proportion of the main defects.CONCLUSION Enterprises should actively improve the production and quality management level of sterile drugs;Regulatory authorities should unify the inspection scale,conduct personalized i nspections based on risks,conduct scientific supervision,assist in the develop ment of enterprises,and effectively safeguard the medication safety of the peop le.