河南省药品GMP认证缺陷分析及新修订《药品管理法》实施后的建议  

Analysis on the Defects of Drug GMP Certification Inspection in Henan Province and Recommendations after the Implementation of Newly Revised Drug Administration Law

作　　者：金建闻 党明安 谢芝丽 JIN Jian-wen;DANG Ming-an;XIE Zhi-li(Henan Province Food and Drug Evaluation and Inspection Center,Zhengzhou 450000,China)

机构地区：[1]河南省食品药品审评查验中心,郑州450000

出　　处：《中国药学杂志》2021年第2期162-166,共5页Chinese Pharmaceutical Journal

摘　　要：目的发现河南省药品生产企业在GMP认证方面存在的共性问题,对药品生产企业存在的主要风险点进行分析,并提出措施和建议,为新修订《药品管理法》的实施提供参考。方法对河南省210份GMP认证现场检查报告中的缺陷项目进行统计分析。结果与结论新修订《药品管理法》实施后,药品生产企业需要关注质量控制与质量保证、文件管理、设备等方面存在的问题,有针对性地进行持续改进和提升。药品监管部门通过转变监管模式,提高检查频次等方式加强监管,防止药品安全事故的发生。OBJECTIVE To discover the common deficiency in GMP certification existing in pharmaceutical enterprises of Henan Province,analyze the existing main risk point,offer some measures and suggestions and provide reference for implementing the newly revised Drug Administration Law.METHODS All defective items found in the 210 on-site inspection reports for GMP certification of pharmaceutical enterprises were statistically analyzed.RESULTS AND CONCLUSION After the implementation of the newly revised Drug Administration Law,drug manufacturers need to pay attention to the problems in quality control and quality assurance,document management,equipment and other aspects,and make continuous improvement and promotion accordingly.Drug regulatory departments enhance supervision by changing the supervision mode and increasing the inspection frequency and prevent the occurrence of drug safety accidents.

关 键 词：GMP认证 缺陷 分析 建议 药品管理法 

分 类 号：R95[医药卫生—药学]