What is Out of Trend (OOT)?
Out of trend is defined as a result of a sequence of the analytical results which conform to the specifications but not in the expected trend with respect to the initial or expected result. OOT reveals that there may be a problem with the analysis or the production process. The main purpose of OOT is to lay down a procedure for managing out-of-trend results in active raw material, finished product, stability study, environmental monitoring & water trend in pharmaceutical industries.
ComplianceQuest’s Lab Investigation Solution can provide you with a systematic, efficient, and compliant approach to laboratory investigations to check past activities and the history of lab investigations done. CQ’s lab investigation solution is simple for users to get to the assignable or root cause of every out-of-trend (OOT) test result and then act on it with agility with the help of comprehensive documentation and simplified collaboration. Thus, you can minimize rework and refer to past work quickly and efficiently.
Handling Out of Trend (OOT) is of utmost importance to Pharma and Biotech sectors. Pharma and Biotech companies should perform stability tests at regular intervals to find the status of the samples of raw materials, in-process materials, bulk products, and finished products. OOT results are time-dependent or stability results that fall outside a prediction interval or fail a statistical process control criterion during a stability study.
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