Drugs

Topical Ophthalmic Quality Guidance

FDA has published a draft guidance, Quality Considerations for Topical Ophthalmic Drug Products, with quality considerations for gels, ointments, and liquid formulations. The document specifically discusses:

microbiological considerations;
approaches for evaluating visible particulate matter, extractables and leachables, and impurities and degradation products;
the use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms;
recommendations for design, delivery, and dispensing features of container closure systems (CCS); and
recommendations for stability studies.

FDA says the guidance revises the 10/2023 draft guidance on the same name by adding microbiological considerations related to product sterility for all ophthalmic drug products and the prevention of contamination of ophthalmic drug products packaged in multiple containers.

The guidance includes an Introduction, Microbiological Considerations, Visible Particulate Matter, Extractables and Leachables, Impurities and Degradation Products, In Vitro Drug Release/Dissolution Testing for Quality, CCS Design and Delivery and Dispensing Characteristics, Stability, and a Glossary.

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