ICH Q3D Elemental impurities

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMA/CHMP/ICH/353369/2013
Effective from

01/06/2016 (for new marketing authorisation applications)

01/12/2017 (for authorised medicinal products)

KeywordsElemental impurities, limit, safety, routes of administration, toxicity, permitted daily exposure (PDE), risk assessment, control, specification, analytical
DescriptionThis 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.


Document history

Implementation strategy

Implementation strategy of ICH Q3D guideline


Discussion paper for implementation strategy of ICH Q3D guideline

Published: 08/03/2017


Published: 12/07/2016

Revision 1

In progress

Draft ICH guideline Q3D (R1) on elemental impurities, Step 2b

Published: 16/05/2018

Deadline for comments on the revised Cadmium inhalation PDE: 16/08/2018

First version

Current version

Adopted guideline




Draft guideline

In operation: 

  • 01/06/2016 (for new marketing authorisation applications)-present
  • 01/12/2017 (for authorised medicinal products)-present


Published: 08/08/2013

Superseded documents

Adopted guideline


Overview of comments


Draft guideline


Note for guidance

In operation: 01/08/2008–01/06/2016


Published: 26/05/2009


Published: 01/01/2007


Published: 17/12/2002

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