FDA - DNA Reactive (Mutagenic) Impurities in Pharmaceuticals

FDA has issued a new guidance document: “M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk - Guidance for Industry.”

This guidance 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.

The document can be accessed here: FDA

 Posted by Tim Sandle