FDA Revision to the Guidelines on Quality Considerations for Ophthalmic Drug Products

FDA has updated its guidance on Quality Considerations for Ophthalmic Drug Products in response to recent incidents of microbial contamination and safety recalls. The revised draft emphasizes product sterility and preservative use, applicable to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.

Ophthalmic drug products encompass FDA-regulated drugs used for topical delivery around the eye, including solutions, suspensions, emulsions, gels, and creams. The guidance aligns with current good manufacturing practice (cGMP) requirements, emphasizing product sterility as a critical quality attribute (CQA). Manufacturers must adhere to cGMP to ensure sterility and submit relevant documentation in drug applications' chemistry, manufacturing, and controls (CMC) section for FDA review.

Furthermore, the guidance stresses the evaluation of extractables and leachables (E&Ls) from container closure systems (CCS) to prevent potential interactions that could compromise product quality. While semipermeable plastic CCSs may leach compounds into the drug product, glass containers pose fewer concerns.