CRED Getting the CMC Dossier Right 2024

28/08/2024

Justification of Specifications

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Justification of Specifications (1)

• Justification of Specification (3.2.P.5.6) is CRITICAL •

Explains why a test is included and how acceptance criteria were established • Provides rationale for adopting other or alternative approaches • Justifies periodic / skip testing • Provides grounds for omission of tests, especially when these are mentioned in guidance

• Each procedure and each acceptance criterion should be justified

• Presentation of test results in graphical format may be helpful in justifying individual acceptance criteria, e.g. assay and impurities showing trends, projected data and confidence intervals

• Data from development work alongside batches manufactured by the proposed commercial process

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