Screening for quality with process analytical technology in a health-system pharmacy: A primer.

Autor:	Almeter PJ; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Isaacs JT; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA., Hunter AN; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA., Lyman TA; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA., Zapata SP; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA., Henderson BS; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA., Larkin SA; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Long LM; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Bossle MN; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Bhaktawara SA; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Warren MF; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Lozier AM; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Melson JD; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Fraley SR; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Relucio EHL; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Felix MA; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA., Reynolds JW; Department of Finance, University of Kentucky HealthCare, Lexington, KY, USA., Naseman RW; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Platt TL; Department of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY, USA.; Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY, USA., Lodder RA; Pharmaceutical Sciences Department, College of Pharmacy, University of Kentucky, Lexington, KY, USA.
Jazyk:	angličtina
Zdroj:	American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2024 Jan 24; Vol. 81 (3), pp. e73-e82.
DOI:	10.1093/ajhp/zxad239
Abstrakt:	Purpose: The University of Kentucky Drug Quality Study team briefly reviews the growing concerns over pharmaceutical manufacturing quality in the globalized environment, reviews the historical approach by the US Food and Drug Administration (FDA) that prioritizes process over product in enforcing quality with manufacturers, reviews the science of process analytical technology (PAT) such as near-infrared (NIR) spectroscopy, illustrates the use of PAT methods for assessing uniformity and quality in injectable pharmaceuticals, and demonstrates the application of NIR spectroscopy in a health-system pharmacy setting while maintaining current good practice quality guidelines and regulations (cGxP). Summary: Given that the current approach to monitoring quality in pharmaceutical manufacturing was developed in the late 1960s at a time when manufacturing was mostly domestic, the current approach prioritizes process over product, and the global footprint of manufacturing is straining federal resources to fulfill their task of monitoring quality, an approach to augment the quality monitoring process has been developed. PAT methodologies are supported by FDA for monitoring quality and offer a fast, low-cost, nondestructive solution. Given that the Accreditation Council for Pharmacy Education has not required qualitative/quantitative analysis and drug assaying in the pharmacy curriculum for several decades, the authors spend time explaining the science behind one of these PAT methodologies, NIR spectroscopy. This primer reviews the application of this technology in the health-system pharmacy setting and the relevant clinical applications. Conclusion: Utilizing PAT methodologies such as NIR spectroscopy, health-system pharmacies can gain insights about whether process controls are in place or lacking in FDA-approved formulations. (© American Society of Health-System Pharmacists 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Databáze:	MEDLINE
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