Revised FDA Guidance on Changes for Glass Vials & Stoppers

The U.S. Food and Drug Administration (FDA) has issued the revised Guidance on Container Closure System and Component Changes for Glass Vials and Stoppers, which provides drug manufacturers with recommendations for reporting and implementing some common changes to packaging systems consisting of glass vials and stoppers.

Background

The agency issued the guidance because many of the recommendations in the 2021 guidance are applicable outside the context of the COVID-19 public health emergency. The guidance applies to changes to container closure systems (CCS) for licensed sterile medicinal products, including biological products, administered parenterally, and also discusses the pathways available to applicants to obtain feedback from the agency. In addition, the document discusses risk-based tools and comparability protocols to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers.

Tables describing CCS modifications are included at the end of the guidance document and are derived from existing FDA guidance documents that provide FDA recommendations for reporting categories and submission content for common CMC modifications. These tables provide basic recommendations for the information to be submitted and the reporting category for specific changes. However, the agency may require more information to support the change and may determine that a different reporting category is appropriate based on risk assessment information related to the specific proposed change.

The document replaces the guidance issued in March 2021 titled "COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers". In developing the revised document, the FDA considered comments received on the 2021 guidance. More information is available in the FDA guidance document Container Closure System and Component Changes: Glass Vials and Stoppers.