CRED Getting the CMC Dossier Right 2024

28/08/2024

Release vs. Shelf-life

• Different acceptance criteria for release vs. shelf-life specifications • Tighter acceptance criteria at release vs. during shelf-life Europe

• Regulatory requirement for distinct release and shelf-life specifications (both unopened and in-use when relevant)

• US & Japan

• Release specifications apply throughout shelf-life • Tighter non-registered/house acceptance criteria to ensure product conforms to specification during storage.

• Examples include tests for: • Assay • Related substances • Other CQAs that change on storage, e.g. water content

The Organisation for Professionals in Regulatory Affairs

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In-process tests

• In-process tests conducted during manufacturing process in lieu of formal release testing • Same analytical method used for in-process and formal release testing • Identical or tighter IPC acceptance criteria compared to release • Approach validated to show no change when tested in-process vs. at release

• Examples include tests for:

• pH • Hardness/friability of uncoated tablets

The Organisation for Professionals in Regulatory Affairs

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