ASTM WK75248

    Revision of E3263 - 20 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    (What is a Work Item?)

    Active Standard: E3263 - 20

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



    WK75248


    Keywords

    attribute agreement analysis; logistic regression; maximum safe surface; residue visual inspection; visual residue limit; VRL ;

    Rationale

    Edits are being made, with input from a former MHRA Inspector, to clarify sections of the standard for regulatory understanding and alignment and to make the Standard Practice potentially acceptable to PIC/S.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    12-20-2020

    Technical Contact:
    Andrew Walsh

    Status:
    Draft Under Development