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The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023. The guidance specifically notes recent cases of microbially contaminated ophthalmic drug products leading to serious adverse events, as well as drug product recalls. The agency is offering guidance to drug companies on how to comply with GMP requirements. The draft guidance specifically addresses: Microbiological considerations; Visible Particulate Matter, Extractables and Leachables; Impurities and Degradation Products; In Vitro Drug Release/Dissolution Testing for QC; Container Closure Systems Design and Delivery and Dispensing Characteristics; and Stability.

The guidance is applicable to all ophthalmic drugs products, including approved drug products and OTC monograph drug products. CMC sections of drug applications are also discussed.

Comments may be made to Docket ID FDA-2023-D-4177 by 26 February 2024.

Posted in Drugs, FDA and USDA Regulatory Update.