Qualification of non-genotoxic impurities

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This reflection paper considers the safety evaluation of non-genotoxic impurities (NGI) in chemically synthesised pharmaceuticals and is intended to establish a framework to facilitate future discussions among stakeholders. Qualification of NGI may be required when data from the regular (non-)clinical development with the API batches is not considered sufficient. The aim of this paper is to complement currently available guidelines addressing qualification of NGI such as ICH Q3A and ICH Q3B. The reflection paper discusses different non-animal approaches, which may provide more compound-specific information than animal studies with API batches containing the impurities at low levels.

Keywords: Non-genotoxic impurities, pharmacology, toxicology, threshold of toxicological concern, read across, animal testing, in vitro testing, 3R’s


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