- Published: Tuesday April 11 2017 09: 45
The purpose of this paper is to address specific considerations to enable the practical implementation of ICH Guideline for Q3D Elemental Impurities in the European Union. It is Intended to Provide Guidance for Applicants / MAHs, drug product, drug substance and vehicle manufacturers, as well as regulators. In addition to new applications, it will aussi apply to changes 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 lath guideline Focuses on control of metals intentionally added During the synthesis of the drug substance;
• That the form acknowledges this is one of the MOST significant sources of elemental impurities, drank aussi takes into account other sources and therefore includes Elements not used as Catalysts and reagents.