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How we can determine OOT limit in Stability
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Answer Posted / bhupalreddy
An OOT result shall be identified by comparing the result
to a predetermined acceptable range. Any result outside
this range shall be considered as an OOT.
To identify the OOT result, there are two methods.
1. Extensive Review Range
2. ±3 Sigma Method
If number of batches are less than 50, extensive review
range method shall be followed
If number of batches are more than 50, +/- sigma method
should be followed
After completion of 50 batches/5 intervals, average and
standard deviation of the respective parameter
shall be calculated. Further ±3 sigma values shall be
defined as below
+3 sigma = Average + (3 x Standard deviation)
-3 sigma = Average - (3 x Standard deviation)
Ex: Assay : 98.00% to 101.00%
Average of 50 batches : 99.81%
Standard deviation : 0.20
+3 sigma = 99.81 + (3 x 0.20) = 100.41%
-3 sigma = 99.81 – (3 x 0.20) = 99.21%
OOT range : ‘98.00 to 99.20%’ and ‘100.42%
to 101.00%
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