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Container And Closure System Integrity Testing In Lieu Of Sterility Testing As A Component Of The Stability Protocol For Sterile Products
April 14, 2008
•White Paper: Container And Closure System Integrity Testing In Lieu Of Sterility Testing As A Component Of The Stability Protocol For Sterile Products
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 This guidance document finalizes the draft guidance of the same title dated January 1998 (January 28, 1998, 63 Federal Register (FR) 4272).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.
The purpose of stability testing is to provide evidence on how the quality of a substance or product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, which enables you to establish or modify recommended storage conditions, retest periods, and shelf life or dating period, as the case may be. This guidance document applies only to the replacement of the sterility test with an appropriate container and closure system integrity test in the stability written testing program (referred to in this guidance as the "stability protocol"), recommending an alternative to sterility testing for supporting the continued capability of containers to maintain sterility. The guidance document does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility.
Click Here To Download:•White Paper: Container And Closure System Integrity Testing In Lieu Of Sterility Testing As A Component Of The Stability Protocol For Sterile Products
