CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.5 Control of Drug Product [2]

Control

Batch Analysis data ➢ At least for representative commercial batches; if appropriate, data of batches used for clinical studies or for justification of acceptance limits

Characterisation of Impurities ➢ For degradation impurities in the product not addressed in 3.2.S.; elemental impurity reports (ICH Q3D); nitrosamine risk assessment (also in module 1)

Justification of Specification

➢ Rationale for chosen quality attributes and acceptance limits; justify differences between release/ shelf-life/ in-use specification

Guidance: ICH Q2/ 3/ 4/ 6; Pharmacopoeias (including monographs for dosage forms and test methods)

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3.2.P.6 Reference Standards or Materials

Control

➢ Documentation that analytical standards for routine controls are suitable for their purpose (if not already in 3.2.S.5)

➢ Primary standards from pharmacopoeial bodies (USP, EDQM) can be used for their purpose

➢ Provide proof of qualification (CoA)

Guidance: ICH M4Q (R1), EMA NtA Vol. 2B

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