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FDA scientist: 108 microbiology reviews reveal common sterility gaps in ophthalmic submissions
Summary
Arlene Chen of OPQ summarized findings from 108 microbiology information requests for ophthalmic suspension ANDAs, saying many submissions lacked sterilization validation, requalification data, media‑fill coverage and adequate preservative testing.
Arlene Chen, a food pharmaceutical scientist in OPQ, told attendees that an analysis of 108 microbiology information requests (IRs) for ophthalmic suspension ANDAs between 2019 and 2025 "revealed some critical sterility gaps." She said those gaps appeared across sterilization validation, hold‑time and process controls, media‑fill simulations and requalification records.
Chen framed the problem as partly driven by the inherent complexity of ophthalmic suspensions, which often require combining sterilization approaches for soluble and insoluble phases and relying on aseptic processing rather than terminal sterilization. She urged manufacturers to consult FDA guidance and relevant ISO standards when preparing submissions and to include validation and requalification evidence for each sterilization step.
