An important part of the document is the Annex 1 providing the example of a risk managementsummary (RMS) which lists the 24 elements of the ich Q3D guideline in a table.
Risk ManagementSummary report should be provided in module 3 of the dossier, in the form of a Table, as described in Annex 1 of this document (preferably in CTD section 3.2.
The ICH Q3D guideline emphasises developing a risk-based control strategy to limit elemental impurities which is summarised in an appropriate "Risk ManagementSummary" document.
ICH Q3D指南强调了开发基于风险的控制策略来限制元素杂质，该方法在“风险管理总结”文件里进行汇总。