An important part of the document is the Annex 1 providing the example of a risk management summary (RMS) which lists the 24 elements of the ich Q3D guideline in a table.
文件中一个重要的部分是附录1，它提供了一个风险管理总结(RMS)的样例，其中以表格方式列出了ICH Q3D指南中的24个元素。
Risk Management Summary 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.
风险管理摘要报告应在申报文件的第3模块中提交，采用表格方式，按本文件和附录1所述形式（最好是在CTD第3.2。
The ICH Q3D guideline emphasises developing a risk-based control strategy to limit elemental impurities which is summarised in an appropriate "Risk Management Summary" 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。
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