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Description - Analytical Chemistry in a GMP Environment by James M. Miller

How to hone your analytical skills and obtain high-quality data in the era of GMP requirements With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features: The drug development process in the pharmaceutical industry Uniform and consistent interpretation of GMP compliance issues A review of the role of statistics and basic topics in analytical chemistry An emphasis on high-performance liquid chromatographic (HPLC) methods Chapters on detectors and quantitative analysis as well as data systems Methods for ensuring that instruments meet standard operating procedures (SOP) requirements Extensive appendixes for unifying terms, symbols, and procedural information

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Book Details

ISBN: 9780471314318
ISBN-10: 0471314315
Format: Hardback
(236mm x 164mm x 30mm)
Pages: 512
Imprint: John Wiley & Sons Inc
Publisher: John Wiley and Sons Ltd
Publish Date: 15-May-2000
Country of Publication: United States

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Author Biography - James M. Miller

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.

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