ASTM WK45530

    Revision of E2898 - 13 Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

    (What is a Work Item?)

    Active Standard: E2898 - 14

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



    WK45530

    1. Rationale

    An additional reference was added to the standard which requires reballoting. This refernce is to another ASTM Standard entitled Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon Attribute and is standard number E2656. It occurs twice in the document section 2.1 where it is listed amoung the references and section 4.4 in the Significance and Use session.


    Keywords

    at-line; in-line; in-process measurements; method development; method verification; multivariate modeling; off-line; on-line; particle characterization; PAT; process analytical; process analytical technology; process analytics; process analyzers; qualification; risk assessment; sampling; validation; vibrational spectroscopy;
    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    03-26-2014

    Technical Contact:
    James Rydzak

    Item:
    001

    Ballot:
    E55 (14-02)

    Status:
    Ballot Item Approved as E2898-2014 and Pending Publication