Out of trend slideshare. Investigations follow a phased approach .

Out of trend slideshare. Jul 31, 2023 · To lay down a procedure for investigating and handling of Out of Trend (OOT) results during testing of Active materials, In-process, Finished product and Stability samples. It defines key terms like out-of-specification, out-of-trend, and atypical results. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Out of Trend or OOT is defined as a result of a sequence of analytical results which conforms to the specifications but not the expected trend with respect to the initial or expected result. This document discusses concepts of change control, out of specifications (OOS), and out of trends (OOT) in pharmaceutical quality assurance. It also outlines a two-phase investigation process conducted by analysts and supervisors to identify potential errors or assignable causes for the results. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to systems or processes. b. Some challenges of implementing OOT May 14, 2025 · Understand Out of Trend (OOT) and how to manage OOT results to ensure data integrity and product quality compliance. Feb 14, 2025 · PURPOSE : To lay down a procedure for investigation and evaluation of Out of Trend results, obtained during the release testing and stability study analysis. fq22 hceobf 7q0bjn a8koetjx tzm fit ptx 37sk cu5wl rr1bnu