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KMID : 1142220170120010001
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.1 ~ p.8
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Overview of US Pharmacopeial Convention and USP-NF Revision
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Song Young-Mi
Yang Seong-Jun
Kim Eun-Jeong
Lee Sun-Hee
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Abstract
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U.S. Pharmacopoeia convention (USP) is a scientific nonprofit organization for publishing the USP-NF and providing the reference standards. The headquarter of USP is located in Rockville, MD, US and USP has laboratories and branch offices in nine countries including China and India. USP is continuously; adding new monographs and general chapters in timely manner, omitting monographs and general chapters that are no longer needed, modernizing the monographs and general chapters to reflect the technology development and the state of the industry practices, and making all components in monographs and general chapters for its clarity. The scientific staffs in USP draft the monographs and the general chapters and then forward drafts to Pharmacopoeial Forum for public review and comment. Prior to publication as official text, all monograph and general chapter proposals must be approved by a Expert Committee members which comprised with scientific volunteers from academicians, practitioners, and other professionals elected on the basis of their knowledge and expertise. USP generally uses the standard revision process in the most cases. However, in some cases USP revises the compendia through an accelerated revision process to expedite the revision process. Pharmacopoeial Forum is the bimonthly online journal in which USP publishes proposed revisions to USP-NF for public review and comment. Better
understanding about USP and USP-NF updates will help for setting the pharmaceutical quality standard and revising Korean Pharmacopoeia.
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KEYWORD
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USP-NF, Monograph Modernization, Pharmaceutical Quality Control
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