ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"
ICH公布“ICH Q3D - 元素杂质”培训模块

The ICH has published the long-announced training modules on the ICH Q3D Guideline "Elemental Impurities". Recently, seven presentations (in one zip file) have been put on the ICH website. The presentations deal with the following topics from the Q3D Guideline:
ICH公布了早就宣称的ICH Q3D指南“元素杂质”的培训模块。最近，7个课件做成的一个压缩文件在ICH官网上公布。课件包括Q3D指南里以下主题：
Module 0: Overview of modules 1 to 9
模块0：模块1-9概览
Module 1: Developing acceptable levels for other routes of administration
模块1：建立其它给药途径的可接受水平
Module 2: Justification for exceeding a Permitted Daily Exposure (PDE)
模块2：超出允许日暴露限（PDE）的论证
Module 3: Developing acceptable levels for elemental impurities not covered by ICH Q3D
模块3：建立IHC Q3D未包括的元素杂质可接受水平
Module 4: Considerations for large volume parenterals
模块4：大容量注射剂的考虑
Module 5: General approaches to risk assessment
模块5：风险评估的通用方法
Module 6: Controls on elemental impurities
模块6：元素杂质的控制
Module 7: Calculations between PDE values and concentration limits
模块7：PDE值和浓度限度之间的计算

The training modules 8 (three examples of a presentation for a risk assessment) and 9 (FAQs) are still in progress and will be published soon.
培训模块8（3个风险评估课件例子）和模块9（常见问题）还在制作中，将于最近公布。

ICH's "Implementation Working Group" which was formed in October 2014 is in charge of the creation of these modules.  It has already elaborated similar training modules for the ICH Q8 - 10 Guidelines and one Q&A document for ICH Q11.
ICH的实施工作组于2014年10月组成，他们负责制订这些模块。截止目前，ICH Q8-10指南已经有了类似的培训模块，ICH Q11有一个问答文件。

The background for the development of the training modules on "Elemental Impurities" is the complexity of the requirements laid down in the Q3D Guideline. This became apparent during its development stage. Many critical comments from companies and industrial associations - mainly during the consultation phase of the guideline -  led the ICH to develop practical assistance to both the industry and the authorities in order to ensure a smooth implementation of the guideline.
制作“元素杂质”培训模块的背景是在Q3D指南里的要求较为复杂。在指南的制订期间就已经很明显了。来自公司和行业协会的许多关键建议---主要是在指南征求意见期间---使得ICH决定要给行业和药监部门提供实践协助，以确保该指南的顺利实施。