Introduction
The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline 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 authorised medicinal products.
Implementation strategy of ICH Q3D guideline