ASTM WK43808

    Work Item: ASTM WK43808 - Revision of E2500 - 07(2012) Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

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    Active Standard: E2500 - 13

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

    1. Rationale

    Goals: Modernize E2500 Background: While E2500 in its current form is still acceptable, new developments like the increased use of single-use equipment make a broader update necessary. Scope: Update E2500 to include stipulations about single use equipment, vendor qualification as well as stronger references to other E2500 documents


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    Work Item Status

    Date Initiated:

    Technical Contact:
    Claus Weisemann

    Draft Under Development