Friday, 2 January 2015

EMA - health based exposure limits

EMA have issued the following document: “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.”

The objective of this guideline is to recommend an approach to review and evaluate pharmacological and toxicological data of individual active substances and thus enable determination of threshold levels as referred to in the GMP guideline. These levels can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning validation.

The document is effective from 1st June 2015.

For details see: EMA

Posted by Tim Sandle