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
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Implementation strategy of ICH Q3D guideline (PDF/105.8 KB)
Adopted
First published: 08/03/2017
Last updated: 08/03/2017
EMA/CHMP/QWP/115498/2017 -
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Draft implementation strategy of ICH Q3D guideline (PDF/92.22 KB)
Draft: consultation closed
First published: 12/07/2016
Last updated: 12/07/2016
Consultation dates: 12/07/2016 to 12/08/2016
EMA/404489/2016
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 2 (PDF/874.49 KB)
Adopted
First published: 03/05/2022
Legal effective date: 24/09/2022
EMA/CHMP/ICH/353369/2013 -
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Overview of comments received on ICH guideline Q3D(R2) on elemental impurities (EMA/CHMP/ICH/353369/2013) (PDF/217.86 KB)
First published: 29/01/2021
EMA/42340/2021 -
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Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b (PDF/369.09 KB)
Draft: consultation closed
First published: 18/09/2020
Last updated: 01/10/2020
Consultation dates: 18/09/2020 to 25/12/2020
EMA/CHMP/ICH/353369/2013 -
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1 (PDF/2.22 MB)
Adopted
First published: 29/03/2019
Legal effective date: 29/03/2019
EMA/CHMP/ICH/353369/2013 -
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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 (PDF/884.4 KB)
Draft: consultation closed
First published: 16/05/2018
Consultation dates: 16/05/2018 to 16/08/2018
EMA/CHMP/ICH/353369/2013 -
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - First version (PDF/822.23 KB)
Adopted
First published: 12/01/2015
Last updated: 28/07/2016
EMA/CHMP/ICH/353369/2013 -
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Overview of comments received on ICH guideline Q3D (R1) on elemental impurities (EMA/CHMP/ICH/353369/2013) - First version (PDF/185.09 KB)
First published: 09/10/2018
EMA/619895/2018 -
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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 (PDF/66.91 KB)
Draft: consultation closed
First published: 08/08/2013
Consultation dates: 08/08/2013 to 31/12/2013
EMA/CHMP/ICH/353369/2013
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Guideline on the specification limits for residues of metal catalysts or metal reagents (PDF/401.18 KB)
Adopted
First published: 21/02/2008
Last updated: 21/02/2008
Legal effective date: 01/09/2008
EMEA/CHMP/SWP/4446/2000 -
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Overview of comments received on draft guideline on the specification limits for residues of metal catalysts (PDF/357.94 KB)
First published: 26/05/2009
Last updated: 26/05/2009
EMEA/410412/2007 -
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Draft guideline on the specification limits for residues of metal catalysts (PDF/753.96 KB)
Draft: consultation closed
First published: 01/01/2007
Last updated: 01/01/2007
CPMP/SWP/QWP/4446/00 corr. -
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Note for guidance on specification limits for residues of metal catalysts (PDF/525.92 KB)
Draft: consultation closed
First published: 17/12/2002
Last updated: 17/12/2002
CPMP/SWP/QWP/4446/00