Issue Date: December 27, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Draft
Quality Considerations for Topical Ophthalmic Drug Products
This guidance discusses certain quality considerations for ophthalmic drug products (i.e., gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions) intended for topical delivery in and around the eye. Specifically, the guidance discusses: Microbiological considerations. Approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products. 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 (CCSs). Recommendations for stability studies.
Download the Guidance Document
