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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