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

  • Email
  • Help

This guideline applies to human and veterinary medicines.

Current effective version

Adopted guideline

Reference numberEMA/CHMP/CVMP/SWP/169430/2012
Effective from01/06/2015
KeywordsShared facilities, risk identification, exposure limits, toxicological data, residual active substances, permitted daily exposure (PDE)
DescriptionThis 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

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/06/2015–present

Published: 06/10/2015

Published: 08/01/2013

Published: 28/10/2011

Related content

How helpful is this page?

Average rating:

 Based on 32 ratings

Add your rating:

See all ratings
6 ratings
6 ratings
6 ratings
7 ratings
7 ratings

Tell us more