Module 3 2019

Section 3.2.S.2.2

➢ This is where the commercial GMP route using the chosen RSM(s) is described including: o Synthetic route as diagram (overall and steps as necessary) with text description of conditions etc o Scale of each step (quantities of reactants, reagents catalysts etc) as ratios or absolute amounts o Typical step yields (ranges) o In process controls and acceptance criteria (Table with full details in 3.2.S.2.4) o Reprocessing criteria and methods

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