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Introduction
Out of specification (OOS): The test results that fall outside the acceptance criteria established
in SOP. (Against Specification limit).
Out of Trend (OOT): The test results that may be within specification but show significant
variation from the historical results.
OOS (out of specification) is the comparison of one result versus predetermined specification
criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.
OOS investigations focus on determining the truth about that one value while OOT
investigations focus on understanding non-random changes
Example:
The specification limit for assay is: 95.0-105.0 % w/w of label claim
Case-1: For a particular batch, the result obtained 94.2 % w/w -This result is out of the
Case-2: The result obtained 95.8 % w/w. Although the results are well within the
specifications, we should compare the result with the previous batches trend. If we found the
average value of the trend as 99.0 % w/w then this batch result (95.8 % w/w) is called out of
trend.
An atypical, aberrant or anomalous result within a series of results obtained over a short period
of time is an OOE result. An OOE result is a result that meets specifications, but is outside the
OOS OOT
OOS: out of Specification OOT: out of trend
Comparison of results vs. a Predetermined Comparison of many historical data values
specs criteria. vs. time.
Event Year
USFDA audited Barr Laboratory, identified attempt of “Test until pass “
1989/1991/ 1992
and other abnormality, Resulted in 483
FDA prosecuted Barr Laboratory, Court directed to FDA to draft the OOS
Feb 1993
guidelines
FDA generated draft OOS guideline Sept 1998
FDA published final OOS guideline Oct 2006
OOS Investigation
Identify appropriate assignable cause for Laboratory error Correct the error, and repeat the
analysis to invalidate the OOS.
Suggest the Corrective and Preventive actions e.g. training to the Analyst, Requalification of
Analyst etc. whatever the scientifically appropriate.
• Investigation at Plant
Tool for OOS Investigation & Related Corrective and Preventive action