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.
DOI https://doi.org/10.22270/ijdra.v5i1.192

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

1. Amidon, G L., Lennernas H, Shah V P, and Crison J R. "A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability," Pharmaceutical Research. 1995; 12:413-20.
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.
3. Meyer M C, Straughn A B, Jarvi E J, Wood G C, Pelsor F R, and Shah V P. "The Bioequivalence of Carbamazepine Tablets with a History of Clinical Failures," Pharmaceutical Research; 1992. 9:1612-16.
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7. Shah, V P, et al., "In Vivo Dissolution of Sparingly Water Soluble Drug Dosage Forms," International Journal of Pharmaceutics. 1995; 125:99-106.
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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.
Issue
Vol 5 No 1 (2017): VOLUME 5, ISSUE 1, 2017
Section
Review
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