This guidance document provides recommendations to manufacturers, for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices. This guidance document finalizes the draft guidance of the same title dated January 1998 (January 28, 1998, 63 Federal Register (FR) 4272).
The recommendations in the guidance document apply to both pre- and post-approval stability protocols for sterile biological products, human and animal drugs, including investigational and bulk drugs. For medical devices, the recommendations in the guidance document apply to stability protocols for those devices labeled as sterile. The guidance can be downloaded from the FDA website.