ECA has issue a document for OOE and OOT result handling with cotent under. Does any body have this material. Can you please share it?
"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"