European Pharmacopoeia Commission declares strategy about elemental impurities & implementation of ICH Q3D guideline

The ICH Steering Committee announced that it planned to move its guideline for elemental impurities (ICH Q3D) to Stage 4 of the ICH process in September 2014.Stage 4 is reached when the Steering Committee agrees that there is sufficient consensus on the draft guideline and adopts an ICH Harmonized Tripartite Guideline. After that, Step 5 is implementation by the regulatory authorities of the ICH Tripartite, which consists of the United States, European Union, and Japan. A strategy for the revision of the related texts in the European Pharmacopoeia has been drawn up by the European Pharmacopoeia Commission as a response.In its June session, as a first step, the European Pharmacopoeia Commission decided to revise chapter 5.20, to replace its content by the ICH Q3D guideline as soon as it has moved to Stage 5 in the European Union.

At present, the European Medicines Agency Guideline on the specification limits for residues of metal catalysts or metal reagentsis applicable to new drug products to be marketed in Europe. In accordance to a previous decision taken in April 2012, the Ph. Eur. intends to introduce a cross-reference to this revised chapter in the general monographs, Substances for Pharmaceutical Use (2034) and Pharmaceutical preparations (2619), at a later stage, making the requirements of the ICH Q3D Guideline legally binding. Additionally, it is planned to delete cross-references to the wet chemical tests for “heavy metals” described in chapter 2.4.8 from all individual monographs, except for monographs on products for veterinary use only.It is currently predicted to publish the revised individual monographs in the 9th edition with an implementation date of 1 January 2017.

Chapter 2.4.20, entitled “Determination of metal catalyst and metal reagent residues”, which focuses on sample preparation and method suitability, will provide additional guidance. Along with other general chapters related to elemental impurities analysis, it will be thoroughly reviewed to align them, if necessary, with the latest requirements and possibilities given by the ICH Q3D guideline. Additionally, the Pharmacopoeial Discussion Group (PDG) at its last meeting in June 2014 decided to start the discussions on the harmonisation of their respective chapters on elemental impurities.