ASTM WK73120

    Revision of E3106 - 18e1 Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

    (What is a Work Item?)

    Active Standard: E3106 - 18e1

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



    WK73120


    Keywords

    acceptance limits; CIP; cleaning development; cleaning validation; PAT; risk-based; science-based;;

    Rationale

    With the approval and publication of E3219, along with new publications, and some new regulatory guidance coming out, the cleaning team has been seeing the need to update the E3106 to include references to the E3219 and these other items. Some definitions need to be added. Some sections need additional text for clarification.

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    Work Item Status

    Date Initiated:
    05-23-2020

    Technical Contact:
    Andrew Walsh

    Status:
    Draft Under Development