ICH Guideline Q3D on Elemental Impurities

What does implementation of ICH Q3D involve and what are the sources of risk?

The introduction of the ICH Q3D Guideline on elemental impurities brings significant changes in regulations on pharmaceutical impurities and challenges for implementation. The guideline introduces the use of a risk-based approach to assess the potential presence of elemental impurities in drug products and it came into effect for new marketing authorisations in June 2016 and will come into effect for authorised medicinal products in December 2017. The implementation of this risk based approach is relevant to all aspects of pharmaceutical production, from the materials used in production equipment to solvents, catalysts, excipients and container closure systems.

The guideline also covers the use of inductively coupled plasma techniques to determine levels of elemental impurities.

Download our slide presentation for a brief tour of the guideline, a summary of the potential sources of risk and key points to consider whilst implementing the guideline.