ICH Q3D Elemental impurities - Scientific guideline

This document presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process provides a platform for developing a risk-based control strategy to limit elemental impurities in the drug product.

Please note that new/revised guideline sections are to be included in the Q3D on elemental impurities - Step 5 - Revision 2 guideline effective from 24 September 2022 (see further down).

The training modules listed below for the implementation of Revision 2 of the guideline can be found on the ICH's website under quality guidelines:

• Q3D training implementation of guidelines for elemental impurities > WG presentations / trainings> Q3D Training Package Module 0-9
• Q3D(R2) guideline for elemental impurities> WG presentations / trainings> Q3D(R2) Step 4 presentation

Keywords: Elemental impurities, limit, safety, routes of administration, toxicity, permitted daily exposure (PDE), risk assessment, control, specification, analytical