CRED Getting the CMC Dossier Right 2024

28/08/2024

➢ Manufacturing process description with ranges and IPCs as required by the Overall Control Strategy (OCS) Drug Substance Development – Registration CTD

➢ Identified and justified starting materials with specifications for starting materials and process inputs as required by the OCS

➢ Intermediate specifications as required by the OCS

➢ DS specification fully justified (following ICH Q3A, Q3C, Q3D, M7)

➢ Control strategy for mutagenic impurities as per ICH M7

➢ Justification of the overall control strategy, specifications, commitments and absence of tests/commitments

➢ Detailed discussion of stability, retest period justification, appropriateness of the analytical methods

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Detailed nitrosamine risk assessment

➢ Detailed analytical method procedures and validation

The Organisation for Professionals in Regulatory Affairs

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Supporting ICH guidelines (1)

● ICH Q1A-F: Stability ● ICH Q3A – Impurities in New Drug Substances ● ICH Q3C: Residual Solvents ● ICH Q3D: Elemental Impurities ● ICH Q6A: Specifications ● ICH M7: Mutagenic Impurities – Draft ICH M7 Q&A is useful context ● ICH S9 – Anticancer Pharmaceuticals – ICH S9 Q&A provides helpful clarifications

The Organisation for Professionals in Regulatory Affairs

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