CGA M-12-2008

$7.15

Investigating Out-of-Specification Test Results for Medical Gas Manufacturing

Published By	Publication Date	Number of Pages
CGA	2008-01-28	10

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Category: CGA

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Description

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.

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