SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE

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

Abstract

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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References

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2. FDA. Center for Drug Evaluation and Research, Guidance for Industry: Immediate Release Solid Oral Dosage Forms. Scale-up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation [SUPAC-IR]; 1995 Nov.
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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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