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.

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 PDF icon questions and answers

Keywords: Shared facilities, risk identification, exposure limits, toxicological data, residual active substances, permitted daily exposure (PDE)

Document history - First version (current)


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