The full form of OOL in the pharmaceutical context is Out of Limit.
Here's a breakdown:
- Out of Limit (OOL): This term refers to a result that falls outside the established acceptable range or specifications for a particular test or analysis. This, along with Out of Specification (OOS) and Out of Trend results, requires investigation in the pharmaceutical industry to ensure product quality and safety.
As stated in the provided reference: "The handling of deviations, i.e. Out of Specification (OOS), Out of Limit (OOL), Out of Trend or atypical test results is unfortunately insufficiently described from a regulatory point of view." This highlights the importance of properly managing OOL results, despite the lack of comprehensive regulatory guidance.
