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Call for comments for SUPAC guidance on Manufacturing Equipment Addendum

  • 1.  Call for comments for SUPAC guidance on Manufacturing Equipment Addendum

    Posted 05-18-2026 06:37

    All MSE community and general AAPS members are invited to provide comments on the FDA guidance document, SUPAC: Manufacturing Equipment Addendum. We will be holding a community session on Thursday, May 21st at 1:00 pm EST to discuss your comments and suggestions in detail.  

    Please join the session on Microsoft Teams: https://teams.microsoft.com/meet/261850949436147?p=7IRanrfxOdUV8l7Wtw

    Meeting ID: 261 850 949 436 147

    Passcode: Sw6BK25c



    ------------------------------
    Heather Frericks Schmidt
    Principal Scientist
    Pfizer Inc.
    Groton CT
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: Call for comments for SUPAC guidance on Manufacturing Equipment Addendum

    Community Leadership
    Posted 05-21-2026 08:14
    Hello all,

    For tomorrow's meeting on comments for SUPAC guidance on Manufacturing Equipment Addendum. Going through the addendum I did not find any information on actual scale-up for the pharmaceutical equipment for various processes. It has information on the operating principles only.  Nothing about their scale-up principles for going from a submission batch in a smaller equipment to a large equipment for the commercial batch. I am attaching a few of my presentations given at USFDA while I was a senior reviewer with CDER/OPQ/OPMA and other copies of documents or articles on scale-up for various
    equipment of their manufacturer for your perusal.

    Thanks Again.

    Masih Jaigirdar