EDQM Publishes Elemental Impurities Guideline

On August 4, 2016, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published

to provide guidance on the implementation of the International Council for Harmonization’s (ICH) Q3D Guideline for Elemental Impurities as it applies to Certificates of Suitability (CEP). The new EDQM guidance applies to both new and existing CEPs.

EDQM’s policy for elemental impurities covered by a CEP to the monographs of the European Pharmacopoeia (Ph.Eur.), in relation to substances within the scope of ICH Q3D, is detailed in the new guidance. The guidance explains the implementation of the policy, which includes providing a risk management summary (RMS) for elemental impurities that may be present in the manufacturing process of the final substance. EDQM provides instructions on how to build an RMS and how to define a control strategy.  The guidance also details what information should be provided on the CEP.

ICH Q3D, which went into effect in the European Union in June 2016 for new marketing authorization applications and applies to authorized medicinal products starting in December 2017, emphasizes a risk-based approach to limiting elemental impurities. It addresses 24 elements and provides permitted daily exposure limits. ICH Q3D considers multiple aspects of manufacturing including equipment, water, and container-closure systems.   

Source: EDQM