Der zunehmende Druck des Gesetzgebers auf die pharmazeutische Industrie steigert die Nachfrage nach Fachkräften, die in Forschung, Entwicklung und Produktion zuverlässig und qualitätssicher arbeiten. Dieser Band ging aus dem einschlägigen Inhouse-Weiterbildungsprogramm von Johnson&Johnson hervor und zeigt dem Analytiker anschaulich, wie die GMP-Vorschriften der FDA im Alltag umzusetzen sind. Angesprochen werden alle wichtigen Analysenverfahren und Methoden, von der Spektroskopie über die Chromatographie bis zur Herstellung von Lösungen. Hervorragend auch zum Selbststudium geeignet! (09/00)
Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.
JAMES M. MILLER, PhD, is Emeritus Professor of Chemistry, Department of Chemistry, Drew University, Madison, New Jersey.
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services and Systems at the Janssen Research Foundation, a division of Johnson & Johnson.
Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.
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Hardcover. Etat : Fair. Gebrochener Buchrücken / Seiten oder Softcover umgeknickt; Vergilbt / ausgeblichen; Abnutzung / Risse - deutlich. In the face of increasing regulatory pressures in the pharmaceutical industry, there is a pressing need for skilled analysts who can uphold scientific practices in laboratories and manufacturing sites globally. This practical guide, rooted in Johnson & Johnson's esteemed in-house training program, offers essential insights for laboratory analysts navigating the Food and Drug Administration's good manufacturing practices (GMP) alongside evolving analytical technologies. Industry experts provide a step-by-step approach to the concepts, techniques, and tools necessary for conducting analyses in an FDA-regulated setting. The guide includes clear instructions on major analytical chemical methods, such as spectroscopy, chromatography, and dissolution. It serves as both a formal training manual and a self-study resource, covering topics like the drug development process, uniform interpretation of GMP compliance, the role of statistics in analytical chemistry, and a focus on high-performance liquid chromatographic (HPLC) methods. Additional chapters address detectors, quantitative analysis, and data systems, along with methods to ensure instruments adhere to standard operating procedures (SOP). Extensive appendixes unify terms, symbols, and procedural information, making it a comprehensive resource for analysts in the field. N° de réf. du vendeur 88c6ec30-f04c-4eab-b8d0-63808795b104
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