ASTM WK46216

    Revision of E2537 - 08 Standard Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing

    (What is a Work Item?)

    Active Standard: E2537 - 08

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



    WK46216

    1. Rationale

    1.Cross reference the FDA Process Validation Guidance of 2011. 2.Cross reference and include where possible the Annex 1. 3.Update referenced documents to include FDA guidance, Annex 1, PDA TR 60, others?


    Keywords

    continuous improvement; continuous quality monitoring; continuous quality verification; process capability analysis; process control strategy; process understanding; real-time release;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    05-22-2014

    Technical Contact:
    Claus Weisemann

    Status:
    Draft Under Development