OOT represents a result that, while within the specification limits, shows an unexpected trend or deviation compared to historical data or expected performance.
Example:
A stability study result shows a gradual decline in potency, which is not typical for the product’s historical trend, even though the result is within the acceptable range.
Implications:
Indicates a potential drift or gradual degradation that may signal a future OOS or quality concern. It requires an investigation to understand the cause and mitigate it.
Use Case:
Often used in stability studies, trending analysis, and process monitoring.
Related Topics:
| Partition Coefficient | Dissociation Constants | Nausea and Vomiting |
| Bioavailability | Biotechnology | Bioinformatics |
Resource Person: Vrunda Thakurdesai