22/23 October 2019
In the course of the introduction of the ICH Q3D Guideline on elemental (metallic) impurities, a number of chapters and several monographs of the European Pharmacopoeia had to be revised. The timeframe available for this is the result of the deadline set by the Committee for Medicinal Products for Human Use (CHMP) from which the ICH Q3D requirements will have to be applied to already authorised medicinal products too. That deadline is the 1st December 2017. The European Pharmacopoeia Commission adapted the timetable for the implementation of ICH Q3D into the European Pharmacopoeia to this deadline.
The EDQM published the next steps for the implementation of ICH Q3D in a press release entitled "Update on the PH.EUR.Policy on Elemental Impurities" dated 11 January 2017. According to it, the plan for the revision of some general chapters and monographs will be as follows:
Those chapters and monographs were adopted at the 156th session of the European Pharmacopoeia Commission in November 2016. They are to be published in Supplement 9.3 (with an implementation date of 1st January 2018).
The European Pharmacopoeia Commission also decided to largely delete elemental impurities tests from monographs; except for monographs regarding substances from natural origin and monographs which describe metals for which no PDE limits have been set in the ICH Q3D guideline (e.g. aluminium and iron). Impurities tests originating from the production process will also be deleted. The control of those impurities is the responsibility of the API manufacturer.
The Commission is currently reviewing all monographs together with different groups of experts. A list of the monographs revised will be soon published.