CRED Getting the CMC Dossier Right 2024

28/08/2024

Considerations in Evolving the FPS (1)

Pharmaceutical development •

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Components/raw material quality

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Formulation development studies

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Physical/chemical/biological properties

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Manufacturing process development

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Container closure development

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Microbiological

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Compatibility

Stability studies •

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Informal and formal ICH studies

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In-use testing

• Impurity characterisation - degradation products, residual solvents, elemental impurities, leachables, pGTIs, etc

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Considerations in Evolving the FPS

Clinical FPS

Commercial FPS

• Requirements to the chemical and pharmaceutical quality documentation concerning IMPs in clinical trials (EMA/CHMP/QWP/545525/2017 Rev. 2) • Content and Format of Investigational New Drug Applications (INDs) for Phase 1Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products • INDs for Phase 2 and Phase 3 Studies - • Chemistry, Manufacturing, and Controls • Industry practice / literature / toxicology daily exposure limits

Legislation •

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Directive 2001/83/EC

• United States Code (Ch9 - FD&C Act) • US Code of Federal Regulations, Title 21 • Pharmacopoeias & other Therapeutic, Biotechnology legally enforceable standards • ICH • Q6A, Q6B, Q3B(R2), Q3C(R2), Q3D(R3), Q3E (draft), M7(R2), Q8(R2), Q2/14 • Regional/country specific guidance • CHMP guidance • FDA MAPPs

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