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Articulo SUPAC - Cambios, Scale Up
Articulo SUPAC - Cambios, Scale Up
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Brahmaiah Bonthagarala
Hindu College of Pharmacy
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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.
4) Documentation that should support the This guidance thus sets forth application
change. For those changes filed in a “changes information that should be provided to CDER to
being effected supplement’’ [21 CFR 314.70 assure continuing product quality and
(c)], the FDA may, after a review of the performance characteristics of an immediate
supplemental information, decide that the release solid oral dose formulation for specified
changes are not approvable. post approval changes.
mixing times and operating speeds within data available: One batch with three months
application/validation ranges. accelerated stability data reported in
supplement; one batch on long-term stability
b. Test Documentation data reported in annual report. Significant body
of data not available: Up to three batches with
i. Chemistry Documentation None beyond
three months accelerated stability data reported
application/compendial release requirements.
in supplement; up to three batches on long-term
ii. Dissolution Documentation None beyond stability data reported in annual report.
application/compendial release requirements.
ii. Dissolution Documentation - Case B
iii. In Vivo Bioequivalence Documentation- dissolution.
None.
iii. In Vivo Bioequivalence Documentation In
c. Filing Documentation-Annual report. vivo bioequivalence study. The bioequivalence
study may be waived if a suitable in vivo/in
2. Level 2 Changes vitro correlation has been verified.
a. Definition of Level This category includes c. Filing Documentation
process changes including changes such as
mixing times and operating speeds outside of Prior approval supplement with justification;
application/validation ranges. annual report (long-term stability data).
a. Definition of Level This category includes A. Objective: To compare the rate and extent of
change in the type of process used in the absorption of the drug product for which the
manufacture of the product, such as a change manufacture has been changed, as defined in
from wet granulation to direct compression of this guidance, to the drug product manufactured
dry powder. prior to the change.