This guidance discusses certain quality considerations for ophthalmic drug products (solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.
Specifically, the guidance discusses:
- 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.
This guidance provides information regarding quality considerations for ophthalmic drug products consistent with the current good manufacturing practice (CGMP) requirements outlined in section 501(a)(2)(B) of the FD&C Act and 21 CFR parts 210 and 211 for all drug products, part 601 for biological products, and part 4 for combination products.
For ophthalmic drug products with a United States Pharmacopeia (USP) monograph, this guidance provides information about applicable criteria from the USP.
This guidance also provides recommendations to industry on the documentation that should be submitted in the chemistry, manufacturing, and controls (CMC) section of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), including BLAs for biosimilar and interchangeable biosimilar products.
The CMC section of NDAs, ANDAs, and BLAs must be included as required by 21 CFR 314.50, 21 CFR 314.94, and 21 CFR part 601, respectively.
Relevant records and other information that demonstrate compliance with CGMP requirements must be made available for FDA review during an inspection conducted under section 704(a)(1) of the FD&C Act or when requested by FDA in advance or in lieu of an inspection as described in section 704(a)of the FD&C Act.
This guidance does not apply to biological products regulated by the Center for Biologics Evaluation and Research.
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