Glass Stoppers and Vials Guidance

FDA has published an immediately effective guidance, Covid-19 Container Closure System and Component Changes: Glass Vials and Stoppers, to collate recommendations for the appropriate reporting category and the content of postapproval change submissions across numerous agency guidances. The document conveys recommendations to holders of NDAs, BLAs, and ANDAs about the reporting and implementation of some common changes to container closure system components consisting of glass vials and stoppers for approved sterile drug products. It also discusses pathways available to application holders to obtain agency feedback. The guidance is to remain in effect only for the duration of the Covid-19 public health emergency declared by HHS.

The guidance contents are Introduction, Background, Regulatory Approach to CMC Changes, Common Changes Related to Glass Vials and Stoppers, Tools to Facilitate Changes to CCD Components, Additional Resources, References, and an Appendix.