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 | |
| Reference number | EMA/CHMP/CVMP/SWP/169430/2012 |
| Published | 24/11/2014 |
| Effective from | 01/06/2015 |
| Keywords | Shared facilities, risk identification, exposure limits, toxicological data, residual active substances, permitted daily exposure (PDE) |
| Description | 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
 questions and answers
. |
Document history
First version Current version | In operation: 01/06/2015–present Published: 06/10/2015 Published: 08/01/2013 Published: 28/10/2011 |
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