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GUIDANCE DOCUMENT

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry Guidance for Industry November 2023

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2020-D-1136
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
This guidance is intended to remain in effect until August 7, 2024, unless superseded by a revised final guidance before that date. For further information, refer to 88 FR 15417, March 13, 2023, available at Federal Register.

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to collate recommendations for appropriate reporting category and the content of postapproval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding 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. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. This guidance does not apply to CCS types other than glass vials and stoppers.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1136.

 
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