Quality Expert Shares Insight on Topical Ophthalmic Drug Products
November 2, 2023 | Clarkston Consulting’s Susan Shockey, an expert in quality and regulatory compliance, was recently featured as a guest columnist with Outsourced Pharma for her expertise on quality considerations relating to topical ophthalmic drug products. Read an excerpt from the piece below or the full article here.
FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance
On Oct. 13, 2023, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products1 to address quality considerations for ophthalmic drug products consistent with the current good manufacturing practice (cGMP) requirements. The guidance also provides recommendations to the industry on the documentation that should be submitted in the chemistry, manufacturing, and controls (CMC) section of NDAs, ANDAs, and BLAs for certain CMC attributes for ophthalmic drug products. It is intended to provide additional guidance on specific quality requirements for the manufacturing and testing of ophthalmic drug products.
This guidance was issued as a response to several recent observations regarding the contamination of eye drops. These included an April 2023 warning letter to Pharmedica for making eye drops that could potentially cause blindness, and a February 2023 FDA notification to consumers to stop using sterile eye drops made in India by Global Pharmaceutical Healthcare due to microbial contamination.