27-29 September 2023
How are OOE and OOT results in the pharmaceutical industry to be recorded and assessed nowadays? To answer this question, the ECA Quality Control Working Group and representatives from authorities and industry compiled a guidance document about the handling of Out-of-Expectation (OOE) and Out-of-Trend (OOT) results.
This 70 page document covers the following issues:
This document also includes seven Annexes; a technical glossary and worked examples to visualize the most important statistical tools and regression methods for a proper setting of stability trend limits.