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The Selection and Control of Starting Materials Should be Governed by Science and Risk-Based Approaches

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Notes

  1. ICH Q11; http://www.ich.org

  2. a. Teasdale, Andrew, Genotoxic Impurities: Strategies for Identification and Control, 221-247 (2010). ISBN: 978-0-470-49919-1, http://eu.wiley.com/WileyCDA/WileyTitle/productCd-0470499192.html b. Teasdale, A., Elder, D. P., Chang, S.-J., Wang, S., Thompson, R., Benz, N. & Sanchez, I. (2013). Risk Assessment of Genotoxic Impurities (GTIs) in New Chemical Entities—Strategies to Demonstrate Control, Organic Process Research & Development, 17(2), 221-230. doi:10.1021/op300268u

  3. ICH M7; http://www.ich.org

  4. The design of the process and efficiency of unit operations is not currently included in the assessment and acceptance of starting material selection and justification (something ICHQ11 did not address).

  5. US Government Accountability Office (GAO), US Food and Drug Administration; Response to Heparin Contamination Helped Protect Public Health, Controls that were Needed for Working with External Entities were Recently Added, GAO-11-95, October 2010.

  6. Letter from the US House of Representatives Committee on Energy and Commerce to Dr. Robert M. Califf, Commissioner of the Food and Drug Administration, 29 Mar 2016.

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Authors and Affiliations

  1. CMC; Pfizer Global Research and Development, Eastern Point Road, PO Box 8013, Groton, CT, 06340-8013, USA

    Timothy J. N. Watson

  2. Pfizer Worldwide Research & Development, Eastern Point Road, PO Box 8013, Groton, CT, 06340-8013, USA

    Roger Nosal

  3. Global Pharmaceutical Commercialization, Merck & Co. Inc., M.S. RY818-B304, P.O. Box 2000, Rahway, NJ, 07065, USA

    John Lepore

  4. Regulatory CMC; AstraZeneca | Global Regulatory Affairs, ROS17, Mill Court, Silk Road Business Park, Charter Way, Macclesfield, Cheshire, SK10 2NA, UK

    Frank Montgomery

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  1. Timothy J. N. Watson
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  2. Roger Nosal
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  3. John Lepore
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Correspondence to Timothy J. N. Watson.

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Watson, T.J.N., Nosal, R., Lepore, J. et al. The Selection and Control of Starting Materials Should be Governed by Science and Risk-Based Approaches. AAPS J 19, 1–3 (2017). https://doi.org/10.1208/s12248-016-9960-8

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  • DOI: https://doi.org/10.1208/s12248-016-9960-8

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