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There could be equipment failures or changes in the raw materials used. The process could be financially OOC (i.e., losing money), or out-of-regulatory-control with cGMP violations.
Oct 1, 2011
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What is OOT and OOS?
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.
What does OOS mean in manufacturing?
Out of specification (OOS) is defined as a result that falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and/or the laboratory.
What is OOS and OOT and OOE?
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 expected variability of the analytical procedure. Out of Trend (OOT) Results.
What is out of trend in pharma?
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control.
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