Nitrosamines & Genotoxic Impurities in Pharmaceutical Development and Manufacturing

The panelists introduce themselves and describe their expertise and experience in nitrosamine impurity research across consultancy, industry, academia, and toxicology.

The panel explores what has driven nitrosamines to become one of the most scrutinised areas in pharmaceutical manufacturing, and why the challenge feels unresolved.

The panel examines where ICH M7, FDA, and EMA frameworks currently stand, exploring gaps, agency divergence, and what defensible data means in a regulatory submission.

The panel digs into the practical difficulties of detecting and quantifying nitrosamines at trace levels, from instrument selection and sample treatment to method validation and transfer.

The panel addresses the quality, availability, and reliability of reference standards, and explores where stable isotope-labelled internal standards add the most analytical value.

The panel examines how risk assessment strategies are evolving, exploring SAR tools, genotoxicity data, and computational approaches for compounds with uncertain or contested classification.

Drawing on collective experience, the panel reflects on the most common and costly mistakes in nitrosamine impurity management programs, and what organizations could do differently.

The panel shares forward-looking perspectives on where the nitrosamines field is heading analytically, scientifically, and regulatorily over the next three to five years.