Container integrity testing may replace sterility testing for IVDs -- FDA guidance.
This article was originally published in The Gray Sheet
CONTAINER/CLOSURE INTEGRITY TESTING MAY REPLACE STERILITY TESTING in stability protocols for sterile medical devices, drugs and biologics, FDA says in a new draft "Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products." Comments are due March 30.
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