Inhalation MagazineAn overview of general chapter development for oral and nasal drug products (OINDPs) at the US Pharmacopeia (USP): Part 2—Informative chapters <1601>, <1602>, <1603> and <1604>

Publication Date: 12/01/2018
Author(s):
Curry, Paul Hickey, Anthony J. Leiner, Stefan Mitchell, Jolyon P. Poochikian, Guirag Suggett, Jason Zaidi, Kahkashan
Organization(s):
United States Pharmacopeial Convention (USP) Aerosols Sub-Committee of the General Chapters—Dosage Forms Expert Committee
Article Type: Technical Articles
Subjects: Industry Issues and Trends, Product Development/Formulation, Quality by Design (QbD), Testing, Validation, and Regulatory Compliance

This is the second article of a two-part series that provides an overview of the work currently undertaken by members of the Aerosols Sub-Committee at the USP, focusing on recent updates to the normative and informative chapters within the committee’s remit.

This article focuses on the informative chapters that are either official text or are in draft, and fall under the remit of the sub-committee: <1601>, <1602>, <1603> and <1604>. The information provided on draft chapters and is based on previously published Stimuli articles, and should therefore be construed as only being indicative of likely content, given the USP reserves the right to change content, in particular to meet objectives in support of the United States Food and Drug Administration (FDA).

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