OOS refers to a test result that falls outside the established acceptance criteria or specifications set by regulatory bodies or internal guidelines.
Example:
A drug’s potency result is found to be 95%, but the specification range is 98-102%.
Implications:
Indicates a potential quality issue, requiring a formal investigation to determine the root cause and implement corrective and preventive actions (CAPA).
Use Case:
Used for batch release, stability testing, and quality control evaluations.
Related Topics:
| Partition Coefficient | Dissociation Constants | Nausea and Vomiting |
| Bioavailability | Biotechnology | Bioinformatics |
Resource Person: Vrunda Thakurdesai