摘要
目的 在药品上市许可持有人(MAH)制度全面实施的背景下,为解决技术转移传统模式风险高、效率低的局限,探讨质量源于设计(QbD)理念在药品技术转移中的应用。方法 结合QbD的核心要素,构建持有人至受托方的技术转移实施路径,并分析药品生产场地变更备案中的监管要求与审评尺度。结果与结论 持有人需在药品全生命周期贯彻QbD理念,监管部门应聚焦质量设计与风险管理,以保障药品质量一致性与可及性。
Objective Against the backdrop of the implementation of the Marketing Authorization Holder(MAH)system,to address the limitations of high risk and low efficiency in traditional technology transfer models,this study explores the application of the Quality by Design(QbD)concept in pharmaceutical technology transfer.Methods Combining the core elements of QbD,an implementation pathway for technology transfer from the MAH to the contract manufacturing organization(CMO)was constructed.Meanwhile,the regulatory requirements and review criteria for the filing of pharmaceutical manufacturing site changes were analyzed.Results&Conclusion MAHs should implement the QbD concept throughout the entire product lifecycle.Regulatory authorities should focus on quality design and risk management to ensure the consistency and accessibility of pharmaceutical quality.
作者
周卫军
蒋腾
宿军慧
孟兰贞
张一凡
谢正福
沈波
ZHOU Weijun;JIANG Teng;SU Junhui(Evaluation&Inspection Center,Guangdong Medical Products Administration,Guangzhou 510080,China;不详)
出处
《中国处方药》
2025年第24期46-51,共6页
Journal of China Prescription Drug
基金
广东省药品监督管理局2023年科技创新项目(2023TDZ01)。
关键词
MAH制度
质量源于设计
技术转移
委托生产
生产场地变更
Marketing Authorization Holder
Quality by Design
Technology transfer
Contract manufacturing
Manufacturing site change
