ASTM WK66032

    Revision of E2500 - 13 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

    (What is a Work Item?)

    Active Standard: E2500 - 13

    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager



    WK66032


    Keywords


    Rationale

    The attached draft guidance document on Specification, Design and Verification of Pharmaceutical and BioPharmaceutical Manufacturing Systems and is the first major revision of the popular and well received E-2500 (Risk Based Qualification). This version is updated to: Reference Annex 21 Clarify guidance on QAs role within the process Clarify and add detail to help distinguish that only Critical Aspects as derived from the Risk Assessment (which by definition affect Patient Safety and Product Quality) should be qualified.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    11-29-2018

    Technical Contact:
    Louis Traglia

    Item:
    003

    Ballot:
    E55 (19-03)

    Status:
    Negative Votes Need Resolution