Not every problem with quality in pharmaceutical production is an OOS situation. There are plenty of cases when testing gives results in compliance with specifications but at the same time differing significantly from the past records of results or from expected performance. Such contradictions are known as OOE results.
Showing posts with label OOS. Show all posts
OOS Investigation Flowchart
Out of specification investigation flowchart for laboratory stage as well as manufacturing.
Difference Between Out of Specification and Out of Trend
1. OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.
2. OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.
Example:
The specification limit for assay is: 95.0-105.0 % w/w of…
2. OOS investigations focus on determining the truth about that one value while OOT investigations focus on understanding non-random changes.
Example:
The specification limit for assay is: 95.0-105.0 % w/w of…
