药品主文件 (DMF) 的常见缺陷-Green.pdf

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1、Common Deficiencies in Drug Master Files(DMFs)David GreenSenior Pharmaceutical Quality Assessor Division of Product Quality Assessment XVII(DPQA XVII)|Office of Product Quality Assessment III(OPQA III)|Office of Pharmaceutical Quality(OPQ)|Center for Drug Evaluation&Research(CDER)|US FDASBIA Confere

2、nce:Generic Drug Forum 2025April 9-10,2025www.fda.gov2Disclaimer:Opinions expressed in this presentation are those of the speakers and do not necessarily reflect the views or policies of the FDA www.fda.gov3Office of Pharmaceutical Quality(OPQ)MissionThe Office of Pharmaceutical Quality assures that

3、 quality medicines are available to the American publicVisionThe Office of Pharmaceutical Quality will be a global benchmark for regulation of pharmaceutical qualitySloganOne Quality Voicewww.fda.gov4Objective General Considerations regarding Type-II DMFs CTD Format Briefly touch on the contents and

4、 common deficiencies in each section of the drug substance module Brief summary Challenge questionswww.fda.gov5Type-II DMFs:General ConsiderationsType II drug master files(DMFs):Chemistry Manufacturing and Control(CMC)of the active ingredient of a drug productAbsence of adequate informationfail comp

5、leteness assessmentdelay in the DMF becoming adequatedelay in the ANDA approvalUnderstanding of the critical chemistry and manufacturing parameters needed to ensure consistent production of high-quality APIsProvide high quality submissionsA request:It would be extremely helpful for applicants to sub

6、mit a 3938 form with their DMF submissions.www.fda.gov6CTD FormatS Drug Substance ModulesS.1 General PropertiesS.2 ManufactureS.3 CharacterizationS.4 SpecificationS.5 Reference StandardS.6 Container Closure SystemS.7 Stabilitywww.fda.gov7S.1 General InformationS.1.1 Nomenclature International Nonpro