OOS Investigations in a GMP Environment 17 & 18 October 2016, London

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)
  • Specifications
  • 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