The purpose of this document is to address specific considerations to enable the implementation of ICH Q3D Guidelines for Elemental Impurities in the European Union. It is intended to provide guidance for Applicants / MAHs, drug product, drug substance and excipient manufacturers, as well as regulators. In addition to new applications, it will also apply to variations to existing authorized medicinal products.
In the ICH Guideline for Q3D elemental impurities, the focus of the control of elemental impurities is-shifted Compared To the CHMP Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents1. Indeed:
• the latter guideline focuses on control of metals intentionally added during the synthesis of the drug substance;
• it is important that it is one of the most important sources of elemental impurities, as well as those of the other.