Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - Scientific guideline
Table of contents
This guideline applies to human and veterinary medicines.
This 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
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Keywords: Shared facilities, risk identification, exposure limits, toxicological data, residual active substances, permitted daily exposure (PDE)
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Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PDF/169.13 KB)
Adopted
First published: 24/11/2014
Last updated: 24/11/2014
EMA/CHMP/CVMP/SWP/169430/2012 -
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Overview of comments received on 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/ CVMP/ SWP/169430/2012... (PDF/887 KB)
First published: 06/10/2015
Last updated: 06/10/2015
EMA/CHMP/SWP/364535/2015 -
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Draft guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PDF/169.72 KB)
Draft: consultation closed
First published: 08/01/2013
Last updated: 08/01/2013
Consultation dates: 08/01/2013 to 30/06/2013
EMA/CHMP/CVMP/SWP/169430/2012 -
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Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities (PDF/63.97 KB)
Draft: consultation closed
First published: 28/10/2011
Last updated: 28/10/2011
Consultation dates: 20/10/2011 to 31/01/2012
EMA/CHMP/SWP/598303/2011