Thursday, 4 September 2014

DNA reactive (mutagenic) impurities in pharmaceuticals

Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (M7)

This ICH 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. Implementation of M7 is encouraged after publication; however, because of the complexity of the guideline, application of M7 is not expected (with certain exceptions) prior to 18 months after ICH publication.

For details, see ICH

Posted by Tim Sandle