Tablets Capsules

TC0317

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eye on Group (PDG) in partnership with the European Pharmacopoeia (PhEur) and Japanese Pharmacopeia (JP) [5,6]. USP has made steady and signifi- cant progress in updating method- ologies in the USP-NF through col- laborative efforts with the FDA and its stakeholders [1,7,8]. USP Excipient monograph Expert Committees' updates and progress USP Expert Committee (EC) work plans are posted on the USP website. The two Excipient Monograph ECs' (EM1 and EM2) work plans provide a summary of their work during the 2010-2015 revision cycle that includes the area of focus and key issues [9]. Major topics of the 2015-2020 EM1 work plan include reconvening the USP Expert Panel to revise General Chapter <1059> Excipient Performance [10]. This chapter pro- vides an overview of the key func- tional categories of excipients and tests or procedures that can be used by both the user and maker of the excipient to monitor and control criti- cal material attributes or properties of the excipient. This is important because not all the critical physical and chemical properties may be iden- tified in excipient monographs via compendial tests and specifications. The use of excipients in specialized drug delivery systems—such as in bio- logics and injectables—has high- lighted the need to control critical excipient properties that contribute to excipient variability in a dosage form. The expert panel's area of focus for revision includes: • Adding missing USP-NF func- tional categories to include excipi- ents used in specialized dosage forms per <1151> Pharmaceutical Dosage Forms, such as biologics, • Identifying methods that can be introduced into <1059> to support the new NF categories, and • Updating the USP reference table "USP and NF Excipients, Listed by Functional Category." Major topics of the 2015-2020 EM2 EC work plan include the formation of the new Talc Methods expert panel, which held its first meeting in March 2016. The charge of the expert panel is to address the request from the FDA Monograph Modernization Task Group (MMTG) to modernize the high-priority USP-NF talc monograph requesting that, "Labeling should be revised to match the statements that are provided in the Talc FCC mono- graph, thereby assuring that talc is not sourced from mines that are known to contain asbestos. Also, USP should consider revising the current tests for asbestos to ensure adequate specificity" [11]. This expert panel was formed based on the recommendation of the previous talc expert panel under the 2010-2015 Excipient EC, which was charged with identifying the scope of the updates to the USP Talc mono- graph to ensure that the test for absence of asbestos has adequate speci- ficity. This scope was published in a Stimuli article, which addressed the challenges faced in updating the test for absence of asbestos and provided recommendations for the Talc mono- graph update [12]. Based on these rec- ommendations, the current Talc Methods expert panel was formed to Tablets & Capsules March 2017 47 Catherine Sheehan and John A. Giannone USP excipients This edition of the column discusses the updates to and harmonization of excipi- ent USP-NF standards and the impor- tance of stakeholder engagement. Since 1820, the US Pharmacopeial Convention (United States Pharma- copeia, or USP) has published drug standards used in the USA and in more than 140 countries [1]. Additionally, USP produces and sup- plies more than 3,500 reference stan- dards used in testing for drug sub- stances, biologics, excipients, and many other items. Given the broad application of excipients in drug products, dietary supplements, and food ingredients, USP has resolved to update the USP- National Formulary (USP–NF) excip- ient standards by adding or revising specific identification, assay, and impurity tests. These tests help improve testing controls and provide tools to qualify an excipient for its intended use. The complete list of excipient monographs in need of updating can be found on the USP website, along with guidelines for sponsors to submit a request for revi- sion to USP-NF [2-4]. USP employs several approaches that include: • The traditional donor model (externally sourced from a sponsor); • USP laboratories (internally sourced through our USP-China compendial development lab) • USP expert committees and expert panels (which use industry expertise and gain early stakeholder input), and • Harmonization initiatives through the Pharmacopeial Discussion

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