The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines state that qualification is the process of acquiring and evaluating data that establishes the biological
safety of an individual impurity or a given impurity profile at the level(s) specified.
The applicant should provide a rationale for establishing impurity acceptance criteria that includes safety considerations. For DNA reactive (mutagenic) impurities, elemental impurities and residual solvents specific guidance is provided (ICH M7, Q3D and Q3C, respectively). However, for non-genotoxic impurities (NGI) little guidance is available on how these impurities should be qualified.