ICH Q3D Elemental impurities

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference number EMA/CHMP/ICH/353369/2013
Published 05/06/2015
Effective from

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

01/12/2017 (for authorised medicinal products)

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

 

Document history

Implementation strategy

PDF iconImplementation strategy of ICH Q3D guideline

 

PDF iconDiscussion paper for implementation strategy of ICH Q3D guideline

Published: 08/03/2017

 

Published: 12/07/2016

Revision 1

In progress

PDF iconDraft 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

PDF iconAdopted guideline

 

 

PDF iconOverview of comments

 

 

PDF iconDraft guideline

In operation:

Published: 09/10/2018

 

 

Published: 08/08/2013

Superseded documents

PDF iconAdopted guideline

 

PDF iconOverview of comments

 

PDF iconDraft guideline

 

PDF iconNote 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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