ICH Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals

A new guideline has been published which may be of interest to readers.

ICH Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – m7.

The introduction capture the aim of the document and reads:

“This guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.”

For further details, see ICH

Posted by Tim Sandle