Container/closure integrity may replace sterility testing in stability programs -- FDA draft guidance.
Executive Summary
CONTAINER/CLOSURE INTEGRITY TESTING MAY REPLACE STERILITY TESTING in stability protocols for sterile drugs, biologics, and medical devices, FDA says in a draft guidance. FDA released the draft "Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products" on Jan. 28. Comments on the draft are due by March 30.