title: The Selection and Control of Starting Materials Should be Governed by Science and Risk-Based Approaches.
authors.affiliation: CMC; Pfizer Global Research and Development, Eastern Point Road, PO Box 8013, Groton, CT, 06340-8013, USA. timothy.j.watson@pfizer.com.
authors.forename: Timothy J N
authors.initials: TJ
authors.lastname: Watson
authors.affiliation: Pfizer Worldwide Research & Development, Eastern Point Road, PO Box 8013, Groton, CT, 06340-8013, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Nosal
authors.affiliation: Global Pharmaceutical Commercialization, Merck & Co. Inc., M.S. RY818-B304, P.O. Box 2000, Rahway, NJ, 07065, USA.
authors.forename: John
authors.initials: J
authors.lastname: Lepore
authors.affiliation: Regulatory CMC; AstraZeneca | Global Regulatory Affairs, ROS17, Mill Court, Silk Road Business Park, Charter Way, Macclesfield, Cheshire, SK10 2NA, UK.
authors.forename: Frank
authors.initials: F
authors.lastname: Montgomery
mesh_terms: D004345:Drug Industry / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations
keywords: API; GMP; ICH Q11; cGMP; drug substance; justification; pharmaceutical quality system; science and risk; selection; starting material