Can any one suggest any referance guideline from any agency for handling laboratory errors and OOT along with criteria (acceptance limit).
An out-of-trend (OOT) result is one that does not follow the expected trend, either in comparison with previous results collected from past history.
A review of recent Establishment Inspection Reports (EIRs), FDA 483s, and FDA. Warning Letters indicate the identification of OOT data is becoming a regulatory issue for marketed products. Several companies have received 483 observations requesting the development of procedures documenting how OOT results will be identified and investigated. It is important to distinguish between OOS and OOT results. FDA issued revised “OOS guidance” (May 2022) and discussed at many scientific conferences about OOS results.
The FDA guidance indicates in a footnote that "Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend (OOT).
There is no clearly established legal or regulatory basis to require consideration of data within specification but not following expected trends (OOT).
There is a need for an efficient and practical statistical approach to identify OOT results to detect when a batch is not behaving as expected. To judge whether a particular result is OOT, one must first decide what is expected and in particular what data comparisons are appropriate.
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