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.
- Edition:
- 1st
- Published:
- 01/28/2008
- Number of Pages:
- 5
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