Out of Trend (OOT)
A stability result that is still within specification but has moved away from the established trend — an early warning that a specification failure may be coming.
Why in-specification is not enough
A related substance rising from 0.08% to 0.31% against a 0.5% limit passes every pull and still predicts failure before the claimed shelf life. OOT evaluation compares each result to the historical trend, not just to the limit.
What happens next
An OOT triggers an investigation with the same rigour as an out-of-specification result: analytical review first, then manufacturing and packaging assessment, then a decision on shelf life or storage statement.
Related terms
Where this applies
General Injectables
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