ASTM WK37158

    Work Item: ASTM WK37158 - New Guide for Validation of PAT Methods

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    Developed by Subcommittee: E55.01 | Committee E55 | Contact Staff Manager



    1. Scope

    This standard is applicable to process analytical spectroscopic methods conducted near-line, on-line or in-line. It will contain information relvant to validation of classical regression methods as well as chemometric methods. It will include some strategies that may be used to validate difficult on-line methods. Validation of PAT systems needs to have as a subpart the monitoring component separated from it. Spectroscopic monitoring is essential to control as it is in the proving of the limits of monitoring method that you can define your control limits. Spectroscopic monitoring engages a different skill set from those used to do process validation.


    Keywords

    FTIR; Vibrational Spectroscopy; cross validiation

    The title and scope are in draft form and are under development within this ASTM Committee.

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    Work Item Status

    Date Initiated:
    04-10-2012

    Technical Contact:
    James Rydzak

    Item:
    002

    Ballot:
    E55 (13-01)

    Status:
    Ballot Item Approved as E2898-2013 and Pending Publication