Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment

• DOI: 10.1021/acs.oprd.0c00517
• Publication Date: 2021-03-03T23:31:17Z
• Authors: Christopher J. Bo...; Mark D. Argentine; John Donaubauer; Eric L. Elliott; Jared Evans; Timothy Talbot Kr...; Heewon Lee; Rodney Parsons; Jeffrey C. Roberts; Gregory W. Sluggett; Andrew Teasdale; Michael Urquhart; Ke Wang; Ping Zhuang
• Keywords: Purge

ICH M7 provides several risk-based control options to manage mutagenic and potentially impurities (MI PMIs) in the manufacture of pharmaceuticals. A Working Group International Consortium for Innovation Quality Pharmaceutical Development (IQ, www.iqconsortium.org) performed a survey pharmaceutical manufacturers gain insight into use regulatory acceptance impurity strategies across industry. Information on was collected late-stage clinical commercial programs with feedback from FDA, EMA, PMDA. The data show preference Option 4 as it allows utilization process knowledge reduce analytical testing without any compromise patient safety. This approach appeared globally acceptable when appropriately applied. that ability manufacturing purge is strong indicator purity control, provide additional evidence factor calculation proposed by Teasdale et al. produces conservative prediction purging process. As such, predicted factors ratio assessments relative required sound framework controls. Experimental may be generated support offer insufficient assurance control.