OOE refers to a result that is unexpected or deviates from typical patterns based on process, method, or equipment performance but does not necessarily violate specifications or trends.
Example:
A sudden spike in temperature during a production step that does not lead to an OOS or OOT result but is unusual for the process.
Implications:
Triggers a deeper look into process parameters or equipment performance to identify potential underlying issues.
Use Case:
Used in process validation, equipment qualification, and routine production monitoring.
Related Topics:
| Partition Coefficient | Dissociation Constants | Nausea and Vomiting |
| Bioavailability | Biotechnology | Bioinformatics |
Resource Person: Vrunda Thakurdesai