FDA Publish Guidance on Container and Closure Systems Testing

Full Text Here

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 This guidance document finalizes the draft guidance of the same title dated January 1998 (January 28, 1998, 63 Federal Register (FR) 4272).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.2 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 guidanceas 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.
This guidance document provides information that we recommend you consider when you propose using alternative methods to sterility testing to confirm the integrity of a container and closure system throughout the product’s shelf life or dating period. The recommendations in this 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 this guidance document apply to stability protocols for those devices labeled as sterile.
If you currently perform sterility testing as a stability-indicating test as part of a stability protocol, you may continue to do so. If your product is approved for an alternative to sterility testing as a component of your stability protocol, this document is not intended to recommend additional testing requirements.

For Assistance with Quality Aspects of Packaging Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”