ICH Q3D Elemental impurities - Scientific guideline

HumanResearch and developmentScientific guidelines

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

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

English (EN) (874.49 KB - PDF)

First published: 03/05/2022

Implementation strategy

Implementation strategy of ICH Q3D guideline

AdoptedReference Number: EMA/CHMP/QWP/115498/2017Summary:

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.

English (EN) (105.8 KB - PDF)

First published: 08/03/2017Last updated: 08/03/2017

Draft implementation strategy of ICH Q3D guideline

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

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

English (EN) (92.22 KB - PDF)

First published: 12/07/2016Last updated: 12/07/2016

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

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

English (EN) (874.49 KB - PDF)

First published: 03/05/2022

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

Reference Number: EMA/42340/2021

English (EN) (217.86 KB - PDF)

First published: 29/01/2021

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

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

English (EN) (369.09 KB - PDF)

First published: 18/09/2020Last updated: 01/10/2020

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

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

English (EN) (2.22 MB - PDF)

First published: 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

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

English (EN) (884.4 KB - PDF)

First published: 16/05/2018

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

AdoptedReference Number: EMA/CHMP/ICH/353369/2013

English (EN) (822.23 KB - PDF)

First published: 12/01/2015Last updated: 28/07/2016

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

Reference Number: EMA/619895/2018

English (EN) (185.09 KB - PDF)

First published: 09/10/2018

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

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

English (EN) (66.91 KB - PDF)

First published: 08/08/2013

Superseded documents

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

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

English (EN) (401.18 KB - PDF)

First published: 21/02/2008Last updated: 21/02/2008

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

Reference Number: EMEA/410412/2007

English (EN) (357.94 KB - PDF)

First published: 26/05/2009Last updated: 26/05/2009

Draft guideline on the specification limits for residues of metal catalysts

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

English (EN) (753.96 KB - PDF)

First published: 01/01/2007Last updated: 01/01/2007

Note for guidance on specification limits for residues of metal catalysts

Draft: consultation closedReference Number: CPMP/SWP/QWP/4446/00

English (EN) (525.92 KB - PDF)

First published: 17/12/2002Last updated: 17/12/2002

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