SCALE UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 1
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.
Authors and Affiliations
Mounica N. V. N. , Sharmila Reddy V, Evangeline L, Nagabhushanam M. V. , Nagarjunareddy D, Brahmaiah B.
Keywords
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- EP ID EP326650
- DOI 10.22270/ijdra.v5i1.192
- Views 171
- Downloads 0
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