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An article by members of the USP Aerosols Sub-Committee, focusing on recent updates to the normative chapters within the committee’s remit. An overview of general chapter development for oral and nasal drug products (OINDPs) at the United States Pharmacopeia (USP): Part 1—Normative chapters <5>, <601>, <602>, <603> and <604> Kahkashan Zaidi, PhD; Paul Curry, PhD; Anthony J. Hickey, PhD, DSc; Stefan Leiner, PhD; Jolyon P. Mitchell, PhD; Guirag Poochikian, PhD and Jason Suggett, PhD Members of the Aerosols Sub-Committee of the General Chapters—Dosage Forms Expert Committee, United States Pharmacopeial Convention (USP), Rockville, Maryland, US • <601> INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, AND POWDERS—PERFORMANCE QUALITY TESTS • <602> PROPELLANTS • <603> TOPICAL AEROSOLS • <604> LEAK RATE e second article is scheduled to appear in the Decem- ber 2018 issue of Inhalation and will focus on the infor- mative chapters in the <1600> series, which are cur- rently undergoing significant changes. Users of pharmacopeial chapters are strongly encour- aged to discuss specific details concerning their pro- duct(s) with the appropriate regulatory bodies, includ- ing the United States Food and Drug Administration (US FDA), to establish precise requirements for testing, registration and quality control following approval. General Chapter <5> INHALATION AND NASAL DRUG PRODUCTS— GENERAL INFORMATION AND PRODUCT QUALITY TESTS Chapter <5> is one of several general chapters that cover General Requirements for Quality Tests and Assays for the different major dosage forms created in the 2010- 2015 Council of Experts cycle. General quality tests are identified separately from the performance quality tests Introduction The Aerosols Sub-Committee (SC) of the General Chapters—Dosage Forms Expert Committee revises the United States Pharmacopeia (USP) chapters to reflect scientific developments and stakeholder input, as well as to align them with current and evolving regula- tory requirements. e chapters within the responsibil- ity of the Aerosols Sub-Committee are listed in Figure 1. e general chapters of the United States Pharmacopeia –National Formulary (USP–NF) are subdivided. ose with numbers below <1000> are generally "nor- mative" chapters, which have content that may be mandated in order to meet regulatory requirements. Chapters numbered above <1000> are "informative" and contain material that is useful to apply in perfor- mance testing but may not be mandatory with respect to use in regulatory submissions. is article is the first of a two-part series in Inhalation, wherein sub-committee members will provide an over- view of USP chapter content to help readers more clearly understand the purpose and application of each chapter. e focus of the present article is on the follow- ing normative chapters: • <5> INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS This is the first 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. Inhalation April 2018 21