ICH Q3D Elemental impurities

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Current effective version

Adopted guideline

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

In progress

Implementation strategy of ICH Q3D guideline


Discussion paper for implementation strategy of ICH Q3D guideline

Published: 08/03/2017


Published: 12/07/2016

First version

Current version

Adopted guideline


Draft guideline

In operation: see above


Published: 08/08/2013

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