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.
Posted by Tim Sandle
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Pharmaceutical Microbiology Resources