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

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 2

Adopted Reference Number: EMA/CHMP/ICH/353369/2013 Legal effective date: 24/09/2022

Implementation strategy

Implementation strategy of ICH Q3D guideline

Adopted Reference Number: EMA/CHMP/QWP/115498/2017 Summary:

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.

Draft implementation strategy of ICH Q3D guideline

Draft: consultation closed Consultation dates: 12/07/2016 to 12/08/2016 Reference Number: EMA/404489/2016 Summary:

The purpose of this document is to describe the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European context.

Document history

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 2

Adopted Reference Number: EMA/CHMP/ICH/353369/2013 Legal effective date: 24/09/2022

Overview of comments received on ICH guideline Q3D(R2) on elemental impurities (EMA/CHMP/ICH/353369/2013)

Reference Number: EMA/42340/2021

Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b

Draft: consultation closed Consultation dates: 18/09/2020 to 25/12/2020 Reference Number: EMA/CHMP/ICH/353369/2013

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1

Adopted Reference Number: EMA/CHMP/ICH/353369/2013 Legal effective date: 29/03/2019

Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q3D (R1) on elemental impurities - Step 2b - Revision 1

Draft: consultation closed Consultation dates: 16/05/2018 to 16/08/2018 Reference Number: EMA/CHMP/ICH/353369/2013

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - First version

Adopted Reference Number: EMA/CHMP/ICH/353369/2013

Overview of comments received on ICH guideline Q3D (R1) on elemental impurities (EMA/CHMP/ICH/353369/2013) - First version

Reference Number: EMA/619895/2018

Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q3D on elemental impurities - Step 3 - First version

Draft: consultation closed Consultation dates: 08/08/2013 to 31/12/2013 Reference Number: EMA/CHMP/ICH/353369/2013

Superseded documents

Guideline on the specification limits for residues of metal catalysts or metal reagents

Adopted Reference Number: EMEA/CHMP/SWP/4446/2000 Legal effective date: 01/09/2008

Overview of comments received on draft guideline on the specification limits for residues of metal catalysts

Reference Number: EMEA/410412/2007

Draft guideline on the specification limits for residues of metal catalysts

Draft: consultation closed Reference Number: CPMP/SWP/QWP/4446/00 corr.

Note for guidance on specification limits for residues of metal catalysts

Draft: consultation closed Reference Number: CPMP/SWP/QWP/4446/00