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Genotoxic Impurities Reference List

Concept Papers for ICH Guidances  Relevant to Genotoxic Impurities

bullet M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Dated 27 November 2009; Endorsed by the ICH Steering Committee on 9 June 2010.  See Link:  M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities Concept Paper

bullet Final Concept Paper Q3D: Impurities: Guideline for Metal Impurities; Dated 17 July 2009; Endorsed by the Steering Committee on 29 October 2009.  See Link: Q3D Concept Paper: Metal Impurities

Genotoxic Impurities Regulatory Guidances


bullet European Medicines Agency Committee for Medicinal Products for Human Use: Guideline on the Limits of Genotoxic Impurities; Dated 28 June 2006; Finalized  01 January 2007.  See Link:  EMA Genotoxic Impurities Guideline

bullet US Department of Health and Human Services, food and Drug Administration; Genotoxic and Carcinogenic Impurities in Drug Substances and Products:  Recommended Approaches; Dated December 2008.  FDA Draft Genotoxic Impurities Guidance

PhRMA Position Paper


bullet Müller L, Mauthe RJ, Riley CM, Andino MM, Antonis DD, Beels C, DeGeorge J, De  Knaep AG, Ellison D, Fagerland JA, Frank R, Fritschel B, Galloway S, Harpur E, Humfrey CD, Jacks AS, Jagota N, Mackinnon J, Mohan G, Ness DK, O'Donovan MR, Smith MD, Vudathala G, Yotti L. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity. Regul Toxicol Pharmacol. 2006 Apr;44(3):198-211. Epub 2006 Jan 18. PubMed PMID: 16412543. Link to Pubmed Abstract for Muller et. al.