OBJECTIVE: To lay down a procedure for handling of Out of Trend (OOT) results during testing of routine and stability samples in Laboratory and during review of Annual product quality, water trends and environmental monitoring trends in Quality Assurance. SCOPE : This procedure is applicable to tests ...

“OOT” stands for Out Of Trend. It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.

1.0 OBJECTIVE To lay down a procedure for handling of Out of Trend (OOT) results during testing of routine and stability samples in Laboratory and during review of Annual product quality, water trends and environmental monitoring trends in Quality Assurance. 2.0 SCOPE This procedure is applicable to ...