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full name of OOS & OOT ? Dercribe it with details ? why
this is needed in pharma industry ?
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Answer Posted / arvind mishra alchemist
The two terms out-of-trend (OOT) and out-of-specification
(OOS) results are in many cases confused by pharmaceutical
companies and regulatory agencies. OOT results are defined
as a stability result that does not follow the expected
trend, either in comparison with other stability batches or
with respect to previous results collected during a
stability study (1). OOT results are not necessarily OOS,
but they do not look like a typical data point. Although OOT
results are a serious problem, the scientific literature and
regulatory guidelines do not fully address this issue
Methods for identification of OOT results—the
regression-control-chart method, the by-time-point method,
and the slope-control-chart method—and further compare the
z-score method and the tolerance interval in OOT analysis.
The results highlight the need for issuing a regulatory
confirmed guideline for identification of OOT results for
ongoing stability data.
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