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ICH公布"ICH Q3D - 元素雜質"培訓模塊

ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"
ICH公布“ICH Q3D - 元素雜質”培訓模塊

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公布了早就宣稱的ICH Q3D指南“元素雜質”的培訓模塊。最近,7個課件做成的一個壓縮文件在ICH官網上公布。課件包括Q3D指南裏以下主題:
Module 0: Overview of modules 1 to 9
模塊0:模塊1-9概覽
Module 1: Developing acceptable levels for other routes of administration
模塊1:建立其它給藥途徑的可接受水平
Module 2: Justification for exceeding a Permitted Daily Exposure (PDE)
模塊2:超出允許日暴露限(PDE)的論證
Module 3: Developing acceptable levels for elemental impurities not covered by ICH Q3D
模塊3:建立IHC Q3D未包括的元素雜質可接受水平
Module 4: Considerations for large volume parenterals
模塊4:大容量注射劑的考慮
Module 5: General approaches to risk assessment
模塊5:風險評估的通用方法
Module 6: Controls on elemental impurities
模塊6:元素雜質的控製
Module 7: Calculations between PDE values and concentration limits
模塊7:PDE值和濃度限度之間的計算

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.
培訓模塊8(3個風險評估課件例子)和模塊9(常見問題)還在製作中,將於最近公布。

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的實施工作組於2014年10月組成,他們負責製訂這些模塊。截止目前,ICH Q8-10指南已經有了類似的培訓模塊,ICH Q11有一個問答文件。

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 ities in order to ensure a smooth implementation of the guideline.
製作“元素雜質”培訓模塊的背景是在Q3D指南裏的要求較為複雜。在指南的製訂期間就已經很明顯了。來自公司和行業協會的許多關鍵建議---主要是在指南征求意見期間---使得ICH決定要給行業和藥監部門提供實踐協助,以確保該指南的順利實施。

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