Chemistry, Manufacturing and Controls Community

 View Only
Back to discussions
Expand all | Collapse all

Call for Comments - SUPAC guidances

  • 1.  Call for Comments - SUPAC guidances

    Community Leadership
    Posted 4 hours ago
    The FDA has announced the establishment of a docket [https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments. Click or tap if you trust this link.">https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments] to solicit public comment on the following guidances for industry on scale-up and post-approval changes (SUPAC) for specific dosage forms:

    1. Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation

    2. SUPAC-IR Questions and Answers about SUPAC-IR Guidance

    3. Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation

    4. SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation

    5. SUPAC: Manufacturing Equipment Addendum
     
    The purpose of releasing the dockets for public comments is to comprehend the relevance of SUPAC guidances, and revising the documents to improve their utility and effectiveness in light of evolving science.
    Please review the docket and message me by close of business on Friday, April 10, if you are interested in being part of the Regulatory Response Team to provide comments. 
     
    Comments are due by June 1 and the Response Team would need to submit to the SAC by May 8. 
     


    ------------------------------
    Sherilyn Campie M.S.
    Director, Quality Control
    Accord Biopharma
    Raleigh NC
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------