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Technical Report No. 56 (Revised 2026) 超高清版文件.pdfVIP

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  • 2026-03-05 发布于辽宁
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Technical Report No. 56 (Revised 2026) 超高清版文件.pdf

    TechnicalReport

    No.56

    ApplicationofPhase-Appropriate

    QualitySystemsandGood

    ManufacturingPracticetothe

    DevelopmentofBiologicalProduct

    DrugSubstance

    Revised2026

    ©PDA2026

    TechnicalReport

    No.56

    ApplicationofPhase-Appropriate

    QualitySystemsandGood

    ManufacturingPracticetothe

    DevelopmentofBiologicalProduct

    DrugSubstance

    Revised2026

    ISBN:978-1-945584-57-2

    ©2026ParenteralDrugAssociation,Inc.

    Allrightsreserved

    TechnicalReportNo.56(Revised2026)©2026ParenteralDrugAssociation,Inc.i

    AuthorsandContributors

    Co-Leads

    RebeccaA.Brewer

    QualityExecutivePartners,Inc.(QxP)

    AmnonA.Eylath

    ™

    BroadSpectrumGXP,LLC

    NancyKirschbaum,PhD

    NancyKirschbaumRegulatoryConsulting,LLC

    TiffanyBakerJayLochhead

    ValSourceInc.JLPharmaConsulting,LLC

    KurtA.Brorson,PhDLisaMcDermott

    ParexelMilliporeSigma,LifeSciencebusinessofMerck

    KGaA

    AndrewChang

    NovoNordiskIanPardo

    RobertDariusRareGeniXConsulting

    SanofiPamRood

    Genentech

    BiswarupDasGupta

    VertexPharmaceuticalsMattSchmidt

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