Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Keywords Impurity, mutagenic, carcinogenic, DNA - reactive

The purpose of this guideline is to provide a practical framework that is applicable to the identification, categorisation, qualification, and control of these mutagenic impurities, to limit potential carcinogenic risk associated with the exposure to potentially mutagenic impurities. This guideline is intended to complement VICH GL10 and VICH GL11.

This guideline considers both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that remain or are reasonably expected to remain in the final drug substance or VMP.

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