Module 3 Presentations

14/05/2024

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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Summary

 A well understood and well controlled API process saves money and time in the long run  API specifications are easier to develop from a well controlled synthesis  Batch to batch reproducibility (chemical and physical) is enhanced  Should avoid the unexpected happening in late stage development or marketing!

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