Spring Intro 2023

03/03/2023

Presentation of Module 3 – 3.2.S

• Full data in Module 3 • Cross reference to previous applications

• Novel drug substance

– Full documentation in Module 3 – ASMF submitted

• Known drug substance

– Described in European Pharmacopoeia • EDQM CEP • ASMF – Not described in a Pharmacopoeia • ASMF

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1. General Information (Nomenclature, Structure, General Properties) 2. Manufacture ( Manufacturer(s), Description of Manufacturing Process, Process Controls, Control of Materials/Critical Steps and Intermediates, Process Validation, Process Development) 3. Characterisation (Elucidation of Structure/other Characteristics, Impurities) 4. Control of drug substance (Specification & justification, Analytical Procedures & Validation, Batch analysis) 5. Reference standards 6. Container closure system 7. Stability Module 3 – 3.2.S Drug substance

03/03/2023

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