ICH致力于制定统一的ICHQ6R1并推动全球质量标准制定的现代化

1LLwww.fda.govICH Efforts towards Developing a Unified ICH Q6(R1) and Modernizing Global Standards for Specifications Setting Ingrid Markovic, Ph.D.Senior Science Advisor for CMCFDA/CBERRegulatory Chair for ICH Q6 EWG and CBER ICH Quality Lead2024 CMC Strategy Forum JapanTokyo Marriott Hotel, JapanDecember 9-10, 2024International Council for Harmonisation of Technical Requirementsfor Pharmaceuticals for Human Use3What are Specifications?Quality AttributeAnalytical ProcedureAcceptance RangeIdentityPurityPotencyMass SpecHPLCBioassay±0.1% to ±0.5% m/z ratio>98%90-110%1.2.3.Specifications4OutlineBackground DriversTimelinesWays or working Early alignment Next steps 5Quality Discussion Group (QDG) EvolutionPage 5“Develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”2003 ICH Quality Vision2014 IQDG 5 year PlanNovember 20182005-14 ICH Quality Guidelines•ICH M7 mutagenic impuri