Spring Intro 2023

03/03/2023

Common Deficiencies – 3.2.S.2

• Manufacture ( Manufacturer(s), Description of Manufacturing Process, Process Controls, Control of Materials/Critical Steps and Intermediates, Process Validation, Process Development) • Starting materials - complex. If a starting material is complex, information is required on its source/outline of its synthetic route, including information on the use of any residual solvents/catalysts • Need full information on the synthesis of the proposed starting material • Control of solvents and catalysts • Potential impurities formed and their control – potential for carry through to the final active substance • Reagents, solvents and catalysts, Organic impurities, Genotoxic impurities • No Critical process parameters described/no justification for omission given

03/03/2023

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Common Deficiencies – 3.2.S.2 (ctd.) • Manufacture (Description of Manufacturing Process, Process Controls, Control of Materials/Critical Steps and Intermediates • Need to take all ICH Q11 ‘general principles’ into account when selecting a starting material, rather than using selected arguments in order to justify a late stage intermediate as the regulatory staring material. • ICH Q11 Guideline: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Questions and Answers

03/03/2023

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