Glossary
Out of Specification (OOS)
What is Out of Specification (OOS)?
Out of Specification (OOS) events in the pharmaceutical industry refer to test results that fall outside the established specifications or acceptance criteria for a product or process. OOS results can indicate potential quality issues and must be thoroughly investigated to comply with the required standards for identity, strength, quality, or purity.
How does OOS differ from OOE and OOT?
Out of Specification (OOS): Results that are outside the established specifications, indicating a potential failure or quality issue.
Out of Expectation (OOE): Unexpected results that are not necessarily failures but require further investigation.
 Out of Trend (OOT): Data points that deviate significantly from historical trends, though still within specification limits.
How to prevent Out of Specification (OOS) in pharma?
Out-of-Specification (OOS) can be prevented in the pharmaceutical industry by regular equipment calibration and maintenance, following of GMP practices, rigorous analytical method validation, training and competence of personnel, environmental monitoring and control, use of automated solutions, continuous monitoring and data analysis.
