ICH M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

ICH M7 was first introduced in June 2014, undergoing a first revision in July 2017. This chapter looks at the ICH M7 guideline, examining each aspect of the guideline, seeking in doing so to give a comprehensive overview of its practical implementation. The format and structure of ICH M7 is understandably very similar to that of the preceding regional guidelines, with specific sections focused on quality and safety aspects, although terminology does differ. In addition to the overall framework, there are additional sections intended to provide definitive guidance in specific areas, these include: established products, documentation, and case Studies. Similar to drug substance impurities, the guideline makes clear the primacy of ICH Q3B and the identification thresholds for the product. The intention of the Question and Answer document was to promote further harmonization in using this guidance in regulation of mutagenic impurities in pharmaceuticals.