CRED Getting the CMC Dossier Right 2024

05/09/2024

Stability data will determine:

• Shelf life (extrapolation beyond long term storage possible, based on accelerated data) see ICH Q1E

• Whether you need a statistical evaluation (variable data)

• Declaration of storage conditions (CPMP/QWP/609/96 Rev 2), to aligned to label statements in SmPC – None (stable under accelerated) – Store below 30˚C (Stable at 30˚C/65%RH for 12 months) – Store below 25˚C (Stable at 25˚C/60%RH) – Keep container tightly closed (sensitive to moisture) – Store in the original package (sensitive to moisture/light) – Keep the container in the outer carton (sensitive to light)

The Organisation for Professionals in Regulatory Affairs

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When/how to deal with changes during development to ensure this does not invalidate clinical/other data already generated

The Organisation for Professionals in Regulatory Affairs

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