OR WAIT null SECS
The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.
Many COVID-19 treatments and vaccines use glass vials and stoppers as their container closure system (CCS), and supply of these components may become constrained, according to FDA. Because of this, manufacturers may need to update approved applications to make changes to CCS components. FDA, therefore, published guidance on March 4, 2021 providing recommendations for reporting and implementing changes to COVID-19 CCS components that consist of glass vials and stoppers for parenteral sterile drug products and biologics.
“In response to this public health emergency, FDA will consider risk-based approaches to facilitate implementation of chemistry, manufacturing, and controls (CMC) changes to a CCS in an effort to mitigate the disruptive effect of the COVID-19 pandemic. These measures may include, but may not be limited to, recommendations for adjustments to submission content and reduction in reporting categories for CMC changes,” the guidance states.
The guidance discusses regulatory approaches to CMC changes and common changes to glass vials and stoppers. The guidance also discusses risk-based tools for implementing CCS changes and comparability protocols.