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1 1 ICH M7 – Assessment and control of dna reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. https://www.ema.europa.eu/en/documents/scientific‐guideline/ich‐guideline‐m7r1‐assessment‐control‐dna‐reactive‐mutagenic‐impurities‐pharmaceuticals‐limit_en.pdf (accessed October 2020).

2 2 Committee for Medicinal Products for Human Use (CHMP). Guidelines on the Limits of Genotoxic Impurities, London 26th June 2006. CPMP/SWP/5199/02.

3 3 Chmp Safety Working Party (SWP). Question & Answers on the CHMP Guideline on the Limits of Genotoxic Impurities. London, 17 December 2009. EMEA/CHMP/QWP/251344/2006Q&A.

4 4 Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches Draft, Center for Drug Evaluation and Research (CDER) December 2008.

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6 6 ICH Q3B (R2). (2006). Impurities in new drug products ICH. CPMP/ICH/2738/99.

7 7 Final Concept Paper M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, dated 27 November 2009. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Final_Concept_Paper_June_2010.pdf (accessed October 2020).

8 8 ICH S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S9/Step4/S9_Step4_Guideline.pdf (accessed October 2020).

9 9 Overview of comments received by EMA on 'Questions and answers – ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals – Step 2b' (EMA/CHMP/ICH/453684/2016)

10 10 Ames, B.N., Durston, W.E., Yamasaki, E.E., and Lee, F.D. (1973). Proc. Natl. Acad. Sci. U. S. A. 72: 2423–2427.

11 11 ICH guideline Q3C (R6) on Impurities: Guideline for Residual Solvents. EMA/CHMP/ICH/82260/2006.

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15 15 Kroes, R., Renwick, A.G., Cheeseman, M. et al. (2004). Food Chem. Toxicol. 42: 65–83.

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19 19 Dobo, K. and Walker, D.. Genotoxic Impurities, Strategies for Identification and Control. Wiley. ISBN: ISBN 978‐0‐470‐49919‐1.Teasdale Chapter 6

20 20 ICH Q11. Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf (accessed October 2020).

21 21 Elder, D. and Teasdale, A. (2015). Org. Process Res. Dev. 19 (11): 1437–1446.

22 22 Kleinman, M., Baertschi, S., Teasdale, A. et al. (2015). Org. Process Res. Dev. 19 (11): 1447–1457.

23 23 Steve Baertschi. Assessing and controlling mutagenic impurities from degradation. Lhasa 2018 Pharmaceutical Industry and Regulators Symposium, Brazil (24–25 May 2018).

24 24 Barber, C., Amberg, A., and Custer, L. (2015). Regul. Toxicol. Pharmacol. 73 (1): 367–377.

25 25 Greene, N., Dobo, K., Kenyon, M. et al. (2015). Regul. Toxicol. Pharmacol. 72 (2): 335–349.

26 26 Müller, L., Mauthe, R.J., Riley, C.M. et al. (2006). Regul. Toxicol. Pharmacol. 44: 198–211.

27 27 Ellis, P., Kenyon, M., and Dobo, K. (2013). Regul. Toxicol. Pharmacol. 65 (2): 201–213.

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29 29 Teasdale, A., Fenner, S., Ray, A. et al. (2010). Org. Process Res. Dev. 14 (4): 943–945.

30 30 ICH guideline Q9 on quality risk management, September 2015 EMA/CHMP/ICH/24235/2006.

31 31 Teasdale, A., Elder, D., Chang, S.J. et al. (2013). Org. Process Res. Dev. 17 (2): 221–230.