European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

The publication of the final ICH Q3D guideline, which has been announced for September of this year, will lead to extensive revisions to chapters and monographs in the European Pharmacopoeia. Find out in what steps the Pharmacopoeia Commission will proceed.

http://www.gmp-compliance.org/enews_4418_European%20Pharmacopoeia%20Commission%20announces%20Strategy%20for%20Implementation%20of%20ICH%20Q3D_8559,S-AYL_n.html

GMP News: European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

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:

• 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.
• 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.
• 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.
• • 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.

  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.

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clippings

• Q3DImpurities: Guideline for Elemental Impurities
• http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

• Draft Document:
  July 2013

  Q3D

  Concept Paper

  Business Plan

  Work Plan

  Description:

  The Q3D draft Guideline has been relased for consultation under Step 2B of the ICH process in July 2013.

  This new guidance is proposed to provide a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities. An additional Guideline Q3C was developed to provide clarification of the requirements for residual solvents. The proposed new Guideline Q3D would provide similar clarification of the requirements for metals, which are included in the ICH inorganic impurities classification.

   

  Status:

  Step 2b

  EU:

  Transmission to CHMP in June 2013, issued as EMA/CHMP/ICH/353369/2013. Deadline for comments: 31 December 2013

  MHLW:

  Released for consultation, 4 October 2013, PFSB/ELD. Deadline for comments: 29 November 2013

  FDA:

  Published in the Federal Register 23 October 2013, Vol. 78, No. 205, p. 63219-20. Deadline for comments: 23 December 2013

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Q3D Elemental Impurities – Food and Drug Administration

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Guideline for Elemental Impurities – ICH