CRED Getting the CMC Dossier Right 2024

28/08/2024

Justification of Specifications (2)

Justification should refer to •

•

Pharmacopoeial standards

•

ICH/EMA guidelines and legislation

•

Relevant development data

• Data for drug substances and drug products used in toxicology and clinical studies • Results from testing of relevant scale-up, process validation and commercial scale batches • Results from relevant accelerated and long-term ICH stability studies, as appropriate, especially data from primary stability batches. • Results from multiple manufacturing sites, if available • Justifications should account for a reasonable range of analytical and manufacturing variability

The Organisation for Professionals in Regulatory Affairs

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Role of Pharmacopoeias

The Organisation for Professionals in Regulatory Affairs

50

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