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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 20 days ago

    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 17 days ago
    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