FDA Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

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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[附网盘链接]由FDA于过去发布，适用于美国。

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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. 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. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required. II. INTRODUCTION Products labeled as sterile are expected to be free from viable microbial contamination throughout the product's entire shelf life or dating period. For products labeled as sterile, we consider sterility to be a stability characteristic. As a result, the stability protocol should include confirmation of continuing sterility throughout the product's shelf life or dating period. The minimum sterility testing generally performed as a component of the stability protocol for sterile products is at the initial time point (release) and final testing interval (i.e., expiration). Additional testing is often performed at appropriate intervals within this time period (e.g., annually). However, as discussed below sterility tests for the purpose of demonstrating continuing sterility have limitations, with respect to the method's reliability, accuracy, and the conclusions that may be derived from the results. Because of the limitations of sterility tests described below, sterility tests are not recommended as a component of a stability program for confirming the continued sterility throughout a product's shelf life or dating period. Alternative methods may be more reliable in confirming the integrity of the container and closure system as a component of the stability protocol for sterile products. This guidance document does not suggest specific test methods and acceptance criteria (except for references to USP methods), nor does it provide comprehensive lists of tests. You should determine these details based on good scientific principles for each specific container and closure system taking into consideration particular product formulations and, where applicable, routes of administration.

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