ASTM WK73465

    New Guide for Accelerated CMC development, manufacture and supply of therapies and vaccines for use in pandemics such as COVID-19

    (What is a Work Item?)

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



    WK73465

    1. Scope

    This guide provides recommendations for approaches to Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practices (GMP) to support the accelerated development, manufacture and supply of new vaccines and treatments for use in pandemics such as COVID-19.


    Keywords

    Regulatory flexibility; anti-viral; medicine;

    Rationale

    The approaches in this guide can provide a framework for the basis for discussion with regulatory authorities to enable companies to understand the information needed to satisfy regulatory requirements for the Quality module of a Marketing Authorization Application for medicine or vaccine for use in the pandemic, and the Good Manufacturing and Distribution Practices for supply of the medicine, when new medicines must be developed and supplied in accelerated timelines and potentially is large quantities for use around the world.

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

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    07-03-2020

    Technical Contact:
    Graham Cook

    Item:
    002

    Ballot:
    E55 (20-05)

    Status:
    Negative Votes Need Resolution