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

The FDA has just published [i] (March 2021) a guidance note on activities to carry out following changes to glass vials and stoppers.  This is pertinent at the minute as there is a global push for vials and stoppers to supply COVID-19 vaccines and their approach is a risk based one in this pandemic time.  This vaccine push could cause issues with the supply chain, necessitating changes to the container closure system (CCS).  At this time during this public health emergency the FDA is considering requests to submit certain changes to the CCS using a lower reporting category than that recommended in existing guidance if the applicants are experiencing constrained supply of CCS or components.

The changes can fall into a number of categories:

  • Changes to the Properties of Glass Vials and Stoppers: New Drug Applications/Abbreviated New Drug Applications*
  • Changes to the Properties for Glass Vials and Stoppers: Biologics License Applications*
  • Changes to the Source or Site of Manufacture for Glass Vials and Stoppers: New Drug Applications/Abbreviated New Drug Applications*
  • Changes to the Source or Site of Manufacture for Glass Vials and Stoppers: Biologics License Applications*
  • Changes to the Manufacturing or Processing of Glass Vials and Stoppers: New Drug Applications/Abbreviated New Drug Applications*

 

Each of the above categories are split into a number of changes and these changes require potentially increasing levels of activity to mitigate the change.   Significant change from glass to a new material e.g. plastic would require the following information to support the change:

  • Confirmatory batch data, including release and stability data (accelerated and real time), and data to support sterility assurance
  • Extractables and leachables risk assessment and supporting data

Whilst a more minor change of say stopper dimensions would require the following:

  • Confirmatory batch data, including release and stability data (accelerated and real time), and data to support sterility assurance
  • Container Closure Integrity Test data

For further detail please refer to the FDA document.

Irrespective of the significance of the change, a change will require some degree of additional activity ranging from minor notification to a whole tranche of testing and data.

 

For further information/additional resources contact CDER at [email protected]

[i] Docket Number FDA-2020-D-1136