Module 3 2019

3.2.S.2.6 Manufacturing Process Development ➢ Manufacturing process history and changes linked to purity/impurity profiles for nonclinical/clinical batches (safety) ➢ Choice of RSM (why and why not) from proposed synthetic route o Labelled flow diagrams of synthesis of each RSM ➢ Identification of CQAs and Critical Steps and control strategies ➢ Impurity control strategies

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