USA – COVID-19: FDA offers guidance on container closure switches

The COVID-19 pandemic has created unprecedented global demand for raw materials and components of products used in the response to the virus. Supply chains for critical materials such as reagents, test swabs and now the glass vials and stoppers used to hold vaccines and therapeutics have been impacted, necessitating workarounds to keep pace with demand.

With COVID-19 vaccines and several therapeutics using glass vials and stoppers for their container closure systems (CCS), the US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance to facilitate changes to those systems “to mitigate the disruptive effect of the COVID-19 pandemic.”

“The supply of CCS components for FDA-regulated products generally may become constrained as manufacturers respond to the public health emergency related to COVID-19. As a result, manufacturers of FDA-regulated products may need to update their approved applications to make changes to CCS components to meet current product demand or increase supply resilience,” FDA says…