FDA issues revised draft guidance for topical ophthalmic drug products
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Key takeaways:
- The draft guidance cited recent cases of contaminated products and made recommendations to improve safety.
- The guidance applies to all marketed ophthalmic drug products.
The FDA has released a revised draft guidance discussing quality considerations for topical ophthalmic drug products, with the addition of new information related to product sterility and prevention of contamination.
These revised guidelines apply to “marketed products including ophthalmic drug products approved under new drug applications, abbreviated new drug applications and biologics license applications, as well as to over-the-counter monograph drugs, drugs compounded by outsourcing facilities, and the drug or biological product constituent part of a combination product,” according to the Federal Register notice.
The guidance cites recent cases of microbially contaminated products and highlights the importance of complying with good current manufacturing practice requirements, stating multidose ophthalmic drug products “should be appropriately designed and controlled to prevent harmful microbial contamination throughout their shelf life and in-use period, which must be supported by stability data.”
Recommendations in the guidance include microbiological studies performed by manufacturers to ensure the safety of products, as well as the use of a “robust visual inspection program” for particulate matter, evaluation for extractables and leachables and identification of test methods and criteria for impurities and degradation products.”
The FDA also provided design recommendations including tamper-evident packaging, tips that remain sealed until opening, torque specifications for applicants and color-coded caps. In addition, the agency recommended that all topical ophthalmic solutions, emulsions and suspensions have a maximum fill volume of 0.5 mL and all ointments or gels not exceed 1 g. The recommendation for multidose drop products is 20 µL to 70 µL.
Comments and suggestions related to the draft should be submitted by Feb. 26, 2024, at www.regulations.gov or by mail.
Reference:
FDA. Quality considerations for topical ophthalmic drug products. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-topical-ophthalmic-drug-products. Posted December 2023. Accessed Jan. 17, 2024.
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