BRIEFING

 〈789〉 Subvisible Particulate Matter in Intraocular Solutions. This proposal is based on the version of the chapter official as of May 1, 2024. A recent revision to this chapter aimed to increase flexibility by eliminating the requirement for two-stage testing in ophthalmic drug products. However, since this change, there has been an increase in queries asking whether two-stage testing remains a viable option. To address these concerns, this revision clarifies that while the chapter now offers more flexibility, two-stage testing continues to be a viable and acceptable alternative for testing ophthalmic drug products. This allows manufacturers to choose the most suitable approach based on their product and testing requirements.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCDF: D. Hunt)

 Case ID—SUB-2214