1. ICH M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4.pdf
2. Committee for Medicinal Products for Human Use (CHMP) Guidelines on the Limits of Genotoxic Impurities London
3. CHMP Safety Working Party (SWP) Question and Answers on the CHMP Guideline on the Limits of Genotoxic Impurities London
4. Food and Drug Administration Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches Draft