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