Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

This guideline applies to human and veterinary medicines.

Current effective version

PDF icon<b>Adopted guideline</b>

Reference numberEMA/CHMP/CVMP/SWP/169430/2012
Published24/11/2014
Effective from01/06/2015
KeywordsShared facilities, risk identification, exposure limits, toxicological data, residual active substances, permitted daily exposure (PDE)
DescriptionThis document concerns the potential for cross-contamination of medicinal products produced in shared facilities. It aims to recommend an approach for deriving a scientifically based safe threshold value for individual active substances to be applied for risk identification.Read together with PDF iconquestions and answers .


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


Concept paper

In operation: 01/06/2015–present


Published: 06/10/2015


Published: 08/01/2013


Published: 28/10/2011


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