20140730 ECA新闻：欧洲药典委员会宣布实施ICH Q3D的策略

20140730 ECA新闻：欧洲药典委员会宣布实施ICH Q3D的策略2014-08-10 julia翻译 蒲公英

http://www.gmp-compliance.org/enews_04418_European-Pharmacopoeia-Commission-announces-Strategy-for-Implementation-of-ICH-Q3D.html

GMP News
30/07/2014

European Pharmacopoeia Commission announces Strategy forImplementation of ICH Q3D

欧洲药典委员会宣布实施ICH Q3D的策略

In a press release from 7 July 2014, the ICH Steering Committee announced that the finalisation of the ICH Q3D Guideline on Elemental Impurities is planned for September 2014. A press release of the European Pharmacopoeia Commission entitled "The European Pharmacopoeia Commission validates its strategy regarding elemental impurities and the implementation plan of the upcoming ICH Q3D guideline" was released 11 days later. In this release, the Commission explains their approach with regard to the integration of the content of ICH Q3D in the European Pharmacopoeia. This is supposed to be done in the following steps:

ICH筹委会在2014年7月7日宣布其ICH Q3D“元素杂质指南”计划在2014年定稿。11天后，一份刊物发表了欧洲药典的声明，题为“欧洲药典委员会确认其元素杂质的态度及对未来ICH Q3D指南的实施计划”。在该消息中，委员会解释了他们将ICH Q3D内容结合入欧洲药典的方法，该方法分以下几步：

• Chapter 5.20 of the Pharmacopoeia ("Metal catalysts or metal reagent residues"), which so far includes a literal rendition of the EMA Guideline "Specification limits for residues of metal catalysts or metal reagents", will be replaced by the wording of the ICH Q3D Guideline, as soon as it is published as Step 4 document.
• 药典5.20章（金属催化剂或金属试验残留）目前包括了EMA指南“金属催化剂和金属试剂残留限度标准”的内容。一旦ICH Q3D终稿公布，该通论将采用ICH Q3D的文字来替代。
  
  

• Chapter 5.20 will only become legally binding when it is referenced in a pharmacopoeia monograph. For this purpose references to Chapter 5.20 are supposed to be inserted in the general monographs 2034 ("Substances for pharmaceutical use') and 2619 ("Pharmaceutical preparations"). The time at which this will take place, has not yet been fixed and depends on the CHMP, which must formally decide to replace the EMA guideline by ICH Q3D in Chapter 5.20.
• 只有当药典各论中引用了第5.20章时，该章节的要求才是强制的。为此，对第5.20章的引用将会加入通论2034（药用物质）中。实施该步骤的时间尚未确定，要取决于CHMP决定正式采用ICH Q3D取代目前第5.20章中内容的时间。
  
  

• In all individual monographs (except in those that relate to substances for veterinary medicinal products) references to Chapter 2.4.8 will be removed. This Chapter still describes wet chemical tests for heavy metals. A list of the affected monographs will appear in the January 2015 issue of the journal "Pharmeuropa". The publication of the revised monographs is intended for the 9th edition of the European Pharmacopoeia with an implementation date of 1 January 2017.
• 在所有单独各论（除了与兽药相关的物质外）中，对2.4.8章的引用将被删除。该章节描述的仍是化学检验重金属方法。在2015年1月的“欧洲药物”杂志中，会公布受影响的各论清单。修订后的各论将在欧洲药典第9版中公布，自2017年1月1日起实施。
  
  

• Chapter 2.4.20 ("Determination of metal catalyst and metal reagent residues") covering the topics of "sample preparation" and "method suitability", will be reviewed and adapted to the requirements according to ICH Q3D.
• 第2.4.20章（金属催化剂和金属试剂残留的检测）包括了“样品制备”和“方法适用性”。该章节将被重新审核，根据ICH Q3D的要求进行采纳。
  
  

After the revision of the individual chapters and monographs it is at the discretion of the responsible quality control laboratories to choose an appropriate analytical strategy in accordance with the requirements of ICH Q3D.

在药典的各章节和各论被修订后，各负责的质量控制化验室自主根据ICH Q3D的要求来选取适当的分析策略。

举报

多谢提醒！