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.
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources