药品上市后变更风险控制的探讨  

Discussion on the Risk Control of Post-Marketing Drug Changes

作　　者：王洁 陈红英 WANG Jie;CHEN Hong-ying(Guangzhou BaiyunshanMingxing Pharmaceutical Co.,Ltd,Guangzhou GUANGDONG,510250,China)

机构地区：[1]广州白云山明兴制药有限公司,广东广州510250

出　　处：《海峡药学》2024年第5期109-110,共2页Strait Pharmaceutical Journal

摘　　要：目的本文根据药品法规的要求,研究探讨药品在上市后发生变更时如何进行风险控制,为药品生产企业变更风险管理提供参考。方法围绕人、机、料、法、环、以及药政法规多个方面进行风险分析,制定控制措施。结果经过风险分析,制定人员培训、对仪器设备进行确认、修订文件、对生产环境进行确认、按药政法规要求申报变更等措施。结论药品上市许可持有人和生产企业是药品上市后变更管理的责任主体,应当建立变更控制体系,对发生的变更进行分类、风险评估、制定控制风险措施以及研究验证工作,将药品质量风险降至最低。OBJECTIVE In accordance with drug regulatory requirements,this article studiedand exploredhow to conduct risk control when drugs changed after post-marketing,to providereference for risk management of changes in drug production enterprises.METHODS Conducted risk analysis and developed control measures around multiple aspects such as human,machine,material,method,environment,and pharmaceutical regulations.RESULTS After risk analysis,the measures such as personnel training,instrument and equipment validation,document revision,production environment validation,and reporting changes in accordance with pharmaceutical regulations have been formulated.CONCLUSION Drug marketing license holders and manufacturing enterprises are the responsible subjects of post-marketing change management of drugs,and should establish a Change control system to classify,assess risks,develop risk control measures,and conduct research and verification to minimize drug quality risks.

关 键 词：药品上市后变更 变更风险 风险控制 

分 类 号：R969.4[医药卫生—药理学]