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A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies

Barber CG; Antonucci V; Baumann J-C; Brown R; Covey-Crump E; Elder DP; Jordine G; Kallemeyn JM; Molzahn R; Ott MA; Elliott E; Fennell JW; Gallou F; Ide ND; Teasdale A; Urquhart MW; Lauwers D; Looker AR; Lovelle LE; McLaughlin M; Varie DL; Welch D; Schils D; Schulte Oestrich R; Stevenson N; Talavera P;

The ICH M7 Option 4 control of (potentially) mutagenic impurities is based on the use of scientific principles in lieu of routine analytical testing. This approach can reduce the burden of analytical testing without compromising patient safety, provided a scientifically rigorous approach is taken which is backed up by sufficient theoretical and/or analytical data. This paper introduces a consortium-led initiative and offers a proposal on the supporting evidence that could be presented in regulatory submissions.