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Ph. Eur. Chapter 5.15. Functionality-related characteristics of excipients 欧洲药典第5.15章节：辅料的功能相关特性 A Draft of Ph. Eur. Chapter 5.15. "Functionality-Related Characteristics of Excipients" has been published in Pharmeuropa 27.4. 在药典在线27.4中刚公布了欧洲药典第5.15章节“辅料的功能相关特性”的草案。 The non-mandatory chapter has been completely reviewed to better align with ICH guideline Q8 Pharmaceutical Development. The chapter deals with the critical quality attributes (CQAs) of excipients which are identified during pharmaceutical development work resulting in an excipient quality specification. 该非强制章节已经完成了审核，以更好地保持与ICH指南Q8药物研发的一致性。该章节主要讲的是辅料的关键质量属性（CQA），这些属性应在药品研发工作其间进行识别，从而获得辅料质量标准。 It introduces the "quality by design" concept described in the ICH Q8 guideline to excipients which requires a comprehensive understanding of the way their attributes interact in the formulation and with manufacturing processes. 它将ICH Q8中描述的“质量源于设计”概念引入辅料，其中要求具备对辅料属性在处方中的相互作用的方法，以及与生产工艺相互作用的综合知识。 Additionally, the draft emphasizes a certain degree of regulatory flexibility based on the description of the design space (Life Cycle Management). 另外，草案强调了基于设计空间（生命周期管理）的描述，在一定程序可以具有法规灵活性。 在药典在线注册即能下载完整内容。 | 
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