25/26 October 2022
COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the U.S. FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of post approval change submissions for some common changes to container closure systems (CCS) consisting of glass vials and stoppers used for parenteral drug products (e.g. vaccines).
According to the agency, applicants must validate the effects of the change prior to distribution of the drug, and, as appropriate, conduct additional qualification tests or submit information to address product-specific risks as part of that assessment. For example, this additional information to be submitted to FDA could include studies to assess:
Applicable tests and studies are, for example, provided in the United States Pharmacopeia (e.g. USP general chapters <660>, <1660>, <381>) and in the European Pharmacopoeia (e.g. Ph. Eur. chapters 3.2.1 / 3.2.9).
Appendix A of the guidance includes recommended information to support the change together with the recommended reporting category (i.e. prior approval supplement, CBE-30, annual report) for common changes to glass vials and stoppers (used for drugs and biologics). For example changes to
For CCS changes that are the subject of this guidance, the agency considers the following risk-based approaches and existing tools:
For more information please see FDA´s new Guidance COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers.