What is OOT? : Pharmaceutical Guidelines

What is OOT?


Answer:
OOT stands for Out Of Trend. Test results are considered out of trend when results of a batch are found different from the previous batches of same product those were manufactured using the same validated method.

Explanation:
For Example, the assay of previous10 batches of XYZ product was between 98.25% and 101.56% and we obtained assay of a new batch 98.12%.
In this case, the assay of this batch is considered as OOT result.

Related: Difference between OOT and OOS



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