CGA M-12

This publication provides guidance on how a medical gas manufacturer should evaluate out of specification test results. It is based on a review of FDA's October 2006 Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.

This publication applies to traditional batch test release and not to Process Analytical Technology models, since they use process controls and in-process data as the release mechanism. It also applies to chemistry-based laboratory testing of pharmaceuticals, including medical gases. It may also apply to contract firms that perform production or laboratory testing of medical gases.