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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Regulatory SOPP 8401.4 Review Responsibilities for the CMC Section of Biologic License Applications and Supplements

SOPP 8401.1 Version #1 Date: Apr. 8, 2005

Appendix 1 - Table of Assignments

 Product OfficeDiv of Manuf & Prod Quality (DMPQ)
Drug Substance
A. Description And CharacterizationFYI
    1. DescriptionFYI
    2. Characterization / Proof of StructureFYI
        a. Physicochemical Characterization of Reference Stds & LotsFYI
        b. Biological ActivityFYI
B. Manufacturer(s)
    1. IdentificationSharedShared
    2. Floor DiagramFYI
    3. Other ProductsSharedShared
    4. Contamination PrecautionsSharedShared
C. Method(s) Of Manufacture
    1. Raw Materials And ReagentsInsp
    2. Flow ChartsInsp
    3. Detailed DescriptionFYI
        a. Animal SourcesFYI
        b. Cellular SourcesSharedShared
            i. Cell Substrate / Host Cell / Expression Vector SystemFYI
            ii. Cell Seed Lot SystemInsp
        c. Human SourcesFYI
        d. Virus SourcesFYI
        e. Synthetic SourcesFYI
    4. Batch RecordsSharedShared
D. Process ControlsSharedShared
E. Reference Standard(s)FYI
F. Specifications / Analytical Methods
    1. Drug Substance Specifications And TestsFYI
    2. Impurities Profile 
G. Container/Closure SystemFYI
H. Drug Substance StabilityAs noted
Drug Product
A. CompositionFYI
B. Specifications & Methods For Drug Product IngredientsFYI
    1. Drug Substances Including All Active IngredientsFYI
    2. ExcipientsFYI
    3. AdjuvantsFYI
    4. PreservativesAs noted
C. Manufacturer(s)SharedShared
D. Methods Of Manufacture And PackagingAs noted
E. Specifications & Test Methods For Drug/ In Vitro ProductSharedShared
F. Container/Closure SystemFYI
G. Microbiology 
H. LyophilizationFYI
I. Drug Product StabilityFYI
J. Investigational Product/FormulationFYI
K. Environmental Assessment 
L. Method ValidationSharedShared
M. Establishment Description Section