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FDA Issues Updated Guidance on Quality Considerations for Ophthalmic Drug Products


  • PharmaVector Content Desk

The Food and Drug Administration (FDA) has recently released a draft guideline addressing key quality considerations for ophthalmic drug products. The comprehensive guidance is intended to provide manufacturers and stakeholders with clear recommendations for ensuring the safety, efficacy, and quality of ophthalmic products, Specifically-

  • Approaches to evaluating visible particulate matter, extractables and leachables, and degradation products.

  • 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.

The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as to over-the-counter (OTC) monograph drugs.

Few of the salient points from the guidance are-

  • Risk Assessment, Extraction Solvents, Methods and Data from Extractable Studies is recommended to be provided.

  • For Leachable Studies, data from three primary stability batches till expiry period is recommended. Additionally, it is expected to include, Analytical method and its validation, assessment of Leachable profiles and inclusion in Specifications

  • The Agency has recommended the safety thresholds for assessment of leachants into formulated products (With Identification and Qualification threshold being 10 ppm and 20 ppm respectively)

  • The FDA’s recommendation for individual unspecified impurities for Ophthalmic product is different than corresponding threshold, as proposed in ICH-

FDA’s Recommended Thresholds for Unspecified Degradation Products or Impurities in Ophthalmic Drug Product



Recommendation on Container closure, including requirement of temper-evident packaging, tips, torque specifications and color coding is also included.

  • Maximum fill for Single use Ophthalmic product (preservative free) is not more than 0.5 mL and 1 g(for gel/ointment). While for multi doseproduct, drop size is recommended between 20 -70 microlitres. ANDA products are required to have a comparative drop size (± 10% of RLD).

  • Recommendations on Stability study orientations (upright and inverted), Water loss study, Freeze thaw studies (for suspension and emulsion products) and In-use stability of multi-dose products are also clearly enumerated.

While Most of this data had always been submitted and/or requested by the agency during the review, availability of this guideline would certainly help applicant and manufacturer to be aligned with expectations of FDA.

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