Module 3 Presentations

14/05/2024

Section 3.2.S.2 Parts

 2.1 Manufacturers  2.2 Description of Manufacturing Process and Process Controls  2.3 Control of Materials  2.4 Control of Critical Steps and Intermediates  2.5 Process Validation and/or Evaluation Studies  2.6 Manufacturing Process Development

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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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