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  • SUPAC Guidelines – Scale-Up and Post-Approval Changes

    Overview of Scale-Up and Post-Approval Changes (SUPAC)

    The SUPAC guidelines are prepared by the American Association of Pharmaceutical Scientists (AAPS) in association with the United States Food & Drug Administration (FDA) and the United States Pharmacopeia (USP). The guideline looks into manufacturing procedures, and compositional modification changes during scale-up and post-approval in drug production. In pharmaceutical technology, the transfer of a pharmaceutical … Read more