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’ (EMA/CHMP/CVMP/SWP/169430/2012) - Revision 1

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Summary

This questions and answers document is currently being revised following the comments received during the public consultation and the workshop hosted by EMA on generation and use of Health Based Exposure Limits (HBEL), on 20-21 June 2017. In the meantime manufacturers should apply the Health Based Exposure Limits guide to all products and assess/control risk based on this data.