Comprehensive Document about the Handling of OOE and OOT Results

Recommendation

27-29 September 2023
Vienna, Austria

FDA Compliance in Analytical Laboratories
How to implement cGMP requirements in the everyday practice of quality control laboratories

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:

• Regulatory references
• Overview of data management in the laboratory and the analytical process
• Responsibilities for QC and QA
• Purpose of trend analysis
• The concept of control charts
• Detection and handling of OOE results
• Statistical process control (SPC) of continuous and discrete data
• Techniques for the retrospective review of historical data
• Trend analysis in stability testing

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.