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Out-of-Spec (OOS) and Out-of-Trend (OOT) is a Comprehensive Review of the FDA Requirements.Avoiding deficiencies and ensuring continuous Improvement through a complete Investigation process.
OOS is the comparison of one result versus predetermined specification while OOT is the comparison of many
historical data values versus time. It is an utmost importance to Pharma sector. QA persons aware of these two terms
exhaustively. They need to perform stability tests at regular intervals to find the status of the samples of RM, in-
process materials, bulk products, and finished products.
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