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Ph. Eur. 5.20

  • Currently, the EMA Guideline (EMEA/CHMP/SWP/4446/2000), which is reproduced in chapter 5.20 "Metal catalyst or metal reagent residues", is applicable to new drug products to be marketed in Europe.
  • Cross-references to chapter 2.4.8 will be deleted from all individual monographs. The list of the impacted monographs has been published in pharmeuropa 27.2. The revised individual monographs will be published in the 9th edition with an implementation date of 1st January 2017.
  • Chapter 5.20 will be revised with ICH Q3D specifications and will be published in the 9.3 supplement of the Eur. Ph. (1st of January, 2018).
  • The general monograph « pharmaceutical preparations » (2619) will be revised and published in the supplement 9.3 of the Eur. Ph., with a cross reference to the revised chapter 5.20, making mandatory the application of ICH Q3D to all the monographs covered by this general monograph.
  • Chapter 2.4.20 « Determination of metal catalyst and metal reagent residues » (sample preparation and method suitability), will be revised to align with general monographs dealing with elemental impurities.