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

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This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline 
Current under revsion - see below

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.


Document history

Revision 1 

In progress

Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’Published: 09/01/2017

First version 

Current version

Adopted guideline


Overview of comments


Draft 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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