Difference between Out of specification and Out of Trend in Pharmaceuticals.
2. OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.
Case-1: For a particular batch, the result obtained 94.2 % w/w -This result is out of the specification limit. This is called OOS.
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.
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