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The document includes recommendations for the reporting and implementation of changes to container closure system components.
On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products and biologics. The recommendations apply to approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). Pathways available to application holders to obtain feedback from FDA are also presented. Risk-based tools for implementation of changes to CCSs consisting of glass vials and stoppers are provided. This guidance does not apply to CCS types other than glass vials and stoppers.
According to FDA, many COVID-19 products use glass vials and stoppers as their CCS, and the supply of these products may be constrained. Manufacturers, therefore, may need to update approved applications to reflect changes made to CCS components to fill demand. The agency will consider risk-based approaches to implementation of chemistry, manufacturing, and controls (CMC) changes to a CCS so that supply of products is not impeded.
The guidance details common changes related to glass vials and stoppers and provides information on tools that can facilitate changes to CCS components. “FDA may expedite the assessment of a supplement or determine that a different reporting category is appropriate, taking into account public health priorities and the applicant’s rationale and associated risk assessment and mitigation strategy for the proposed change. Should a different reporting category be determined to be appropriate, FDA will notify the applicant and convey its rationale for the determination,” the agency states in the document.
The policy remains in effect until Aug. 7, 2024 unless a revised final guidance is published before then. More information can be found in the Federal Register at https://www.federalregister.gov/documents/2023/03/13/2023- 05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19