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FDA Guidance: Quality Considerations for Ophthalmic Drug Products
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February 15, 2024
FDA published draft guidance providing information regarding quality considerations for ophthalmic drug products consistent with the current good manufacturing practice (CGMP) requirements.
This guidance revises the draft guidance issued in October 2023. This revision adds microbiological considerations related to product sterility for all ophthalmic drug products and the prevention of contamination of ophthalmic drug products packaged in multi-dose containers.
Read the full guidance document here.