US, FDA, Guidance-Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

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Organization: US (FDA) CBER/CDER/CDRH/CVM

Issued February 2008

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US, FDA, Guidance-Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

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