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# Glass Vial, Stopper Guidance
- URL: https://www.fdaweb.com/glass-vial-stopper-guidance/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157423

FDA has published a guidance, *Container Closure System and Component Changes: Glass Vials and Stoppers*, to collate recommendations for appropriate reporting categories and the content of postapproval change submissions across several FDA guidances. The [document](https://www.fda.gov/media/167925/download?ref=fdaweb.com) has recommendations for holders of NDAs, BLAs, and ANDAs about the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally. The guidance also discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. It does not apply to CCS types other than glass vials and stoppers.