ASTM WK40198

    Work Item: ASTM WK40198 - Revision of E2474 - 06 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

    (What is a Work Item?)

    Active Standard: E2474 - 06

    Developed by Subcommittee: E55.01 | Committee E55 | Contact Staff Manager



    1. Rationale

    Standard needs to be reviewed under ASTM policy requirements


    Keywords

    design space; desired state; manufacturing; PAT ; pharmaceutical process design; process analytical technology; process understanding; quality risk management;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    01-04-2013

    Technical Contact:
    Ali Afnan

    Item:
    002

    Ballot:
    E55 (14-01)

    Status:
    Ballot Item Approved as E2474-2014 and Pending Publication