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FDA: preservative effectiveness data often missing for multidose ophthalmic suspensions
Summary
Chen said multidose ophthalmic suspensions require preservative effectiveness testing and reviewers often saw stability batches without AET at or below preservative minimum specifications for proposed shelf life.
Chen reminded the audience that ophthalmic suspensions are typically multidose and therefore require preservative effectiveness testing to ensure preservative performance throughout shelf life. "Ophthalmic suspensions are typically multidose, and that means that they contain a preservative," she said, and reviewers often found stability data missing AET results at or below the minimum preservative specification.
She recommended that at least one primary stability batch be tested for antimicrobial effectiveness testing (AET) at or below the product's minimum preservative specification and that those data be included with the submission to demonstrate preservative performance over the proposed shelf life.
