Pharma companies should be aware of these two terms exhaustively. They need to perform stability tests at regular intervals to find the status of the samples of raw materials, in-process materials, bulk products, and finished products. In simple terms, the result of a stability test conducted by a Quality Analyst QA should always adhere to the previously established specifications or criteria.
Similarly, out of trend OOT is defined as a result that falls outside the trend. QC compares the result of the current test with a set of previous results to check with the on-going trend. 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 Also see:.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since Sign-up for the free email updates for your daily dose of pharmaceutical tips. Visitors are also reading:. You can ask questions related to this post here. But what are their definitions? An OOE result is a result that meets specifications, but is outside the expected variability of the analytical procedure.
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