Exec Director Gilead Sciences, Inc. Foster City, California, United States
Mutagenic impurities require additional control compared to other types of impurities falling under ICH Q3A/B guidelines. The first step is understanding the potential mutagenic / carcinogenic hazards of pharmaceutical impurities. Impurities are classified depending on results from computational modelling, bacterial mutagenicity, and / or carcinogenicity. If an impurity is considered / predicted to be mutagenic and / or carcinogenic (ICH M7 Classes 1-3), then the impurity will be assigned an acceptable intake (AI). This provides chemistry with a target to control the impurity. Of recent years, nitrosamine impurities have been an additional emphasis of risk control given their high carcinogenicity potency and labeled as cohort of concern (CoC) impurities. This session will discuss the strategies for controlling mutagenic impurities under ICH M7 and provide additional context for nitrosamine impurities.
