What is an OOS result?
A result that falls outside established acceptance criteria which have been established in official compendia and /or company documentation.
Approved documents such as:
- Certificates of analysis (C of A’s)
- Drug Master Files (DMFs)
- Official compendia
- Filed applications, approved marketing submissions
- Stability protocol
This course is based on the FDA guideline ‘Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production’, October 2006