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

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 questions and answers

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