Shelf Life
The period during which a product remains within specification when stored under the conditions on its label, supported by stability data rather than extrapolation alone.
How much data supports how long
With long-term data showing little change and low variability, a shelf life of up to twice the available long-term data (capped at twelve months beyond) can be proposed. Significant change under accelerated conditions removes that option.
Committed stability
Approval on extrapolated data comes with a commitment to continue the study to the full claimed period and report any adverse trend — a commitment regulators do check.
Related terms
Where this applies
Oral Solids & Liquids
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