Guidance for Industry: Container and Closure System Integrity Testing – Free Download




This guidance document provides recommendations to you, 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This guidance document finalizes the draft guidance of the same title dated January 1998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).

Manufacturers of drugs and biologics purporting to be sterile must test each batch or lot, as the
case may be, to ensure that the product in question conforms to sterility requirements. 21 CFR
211.167(a); 21 CFR 610.12. Such drugs and biologics are also subject to stability testing
requirements. 21 CFR 211.166. The stability testing requirements include maintaining a written
testing program designed to assess stability characteristics. Manufacturers of medical devices
must validate processes, including sterilization for a device purporting to be sterile. 21 CFR
820.75. Stability testing should be part of the design validation of such devices. In vitro
diagnostic products for human use are required to be labeled with stability information. 21 CFR
809.10. For products labeled as sterile, we consider sterility to be a stability characteristic.

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