October 20, 2023
Draft GFI on ophthalmics, final GFI on alcohol testing issued
FDA has released two new guidance documents this month that APC members will want to familiarize themselves with. The first is a draft guidance titled “Quality Considerations for Topical Ophthalmic Drug Products.”It addresses evaluation of visible particulate matter, extractables and leachables, and impurities and degradation products, the use of in vitro drug release/dissolution testing, and recommendations for container closure systems and stability studies. The comment period is open until 12/12/2023 for this draft GFI.
The second is a final guidance intended for immediate implementation titled “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.” It discusses the importance of properly testing pharmaceutical alcohol to detect methanol contamination or substitution due to the potential public health hazard and establishes a limit for methanol in alcohol of 200 parts per million. Though this GFI is final, the docket remains open for comments at any time.
