• Mounica N.V.N.
  • Sharmila V. Reddy
  • Anusha S.
  • Evangeline L.
  • Nagabhushanam M.V.
  • Nagarjunareddy D.
  • Brahmaiah B.


In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different regulatory authority for manufacturing of product. Here SUPAC guidelines for USFDA are elaborated for production in this review article.

Keywords: SUPAC-Guideline for site changes, batch size, manufacturing, in-vitro dissolution, in-vivo bioequivalence, compendia, Biobatch, SUPAC Regulations.


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How to Cite
N.V.N., M., S. V. Reddy, A. S., E. L., N. M.V., N. D., and B. B. “SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE”. International Journal of Drug Regulatory Affairs, Vol. 5, no. 1, Feb. 2018, pp. 13-19, doi:10.22270/ijdra.v5i1.192.

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