# Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/container-and-closure-system-integrity-testing-in-lieu-of-sterility-testing-as-a-component-of-the-stability-protocol-for-sterile-products-guidance-for-industry/74ac14c8-579f-4c16-8e6c-a9f6c3bbdcdd

> FDA guidance document: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products:  Guidance for Industry. Issue date: February 25, 2008. Get complete insights and analysis.

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## Details

- Title: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: veterinary
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2008-02-25
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2008-D-0060">FDA-2008-D-0060</a>

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