D2S06-Chen-v1.2-FINAL.pdf

1、Common Microbiology Deficiencies for Ophthalmic Suspension Drug ProductsArlene Chen,Ph.D.Pharmaceutical Scientist Division of Pharmaceutical Manufacturing Assessment III,Office of Pharmaceutical Manufacturing Assessment,Office of Pharmaceutical QualityCDER|US FDASBIA|Generic Drugs Forum(GDF)2026 Apr

2、il 22-23,2026www.fda.govwww.fda.gov2Common Microbiology Deficiencies for Ophthalmic Suspension Drug ProductsDisclaimer:Opinions expressed in this presentation are based on the speakers interpretation of current regulations and guidance documents and do not necessarily reflect the views or policies o

3、f the FDAwww.fda.govwww.fda.gov3Overview Background:Manufacturing of Ophthalmic Drug Products Top issues found during quality microbiology review www.fda.govwww.fda.gov4BackgroundManufacturing of ophthalmic suspensions is complex!Nearly all ophthalmic suspensions are filled using aseptic processingM

4、anufacturing of drug products include a combination of different sterilization processes to account for soluble and insoluble phases that are later blended to create a sterile suspension Filtration vs.steam sterilization vs.gamma irradiation Sterile API powder requires additional careContainers,clos

5、ures,and equipment contact parts sterilizationEnvironmental monitoring and control(isolators)www.fda.govwww.fda.gov5BackgroundAPI Insoluble Gamma irradiation Ethylene oxideSlurry(heat stable)Moist Heat SterilizationWater for Injection(WFI),purified water,other soluble excipientsFiltrationMoist Heat

6、SterilizationViscous Components Filtration at high temperaturesMoist heat sterilization(autoclave or within a manufacturing vessel)Container Closure SystemGamma irradiationEthylene oxideMoist Heat Sterilization www.fda.govwww.fda.gov6Compiled Microbiology IRs issued from 2019 to 2025 for ophthalmic