Analytical Chemistry in a GMP Environment: A Practical Guide

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9780471314318: Analytical Chemistry in a GMP Environment: A Practical Guide
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How to hone your analytical skills and obtain high-quality data inthe era of GMP requirements
With increased regulatory pressures on the pharmaceutical industry,there is a growing need for capable analysts who can ensureappropriate scientific practices in laboratories and manufacturingsites worldwide. Based on Johnson & Johnson's acclaimedin-house training program, this practical guide provides guidancefor laboratory analysts who must juggle the Food and DrugAdministration's good manufacturing practices (GMP) rules withrapidly changing analytical technologies. Highly qualified industryexperts walk readers step-by-step through the concepts, techniques,and tools necessary to perform analyses in an FDA-regulatedenvironment, including clear instructions on all major analyticalchemical methods-from spectroscopy to chromatography todissolution. An ideal manual for formal training as well as anexcellent self-study guide, Analytical Chemistry in a GMPEnvironment features:
* The drug development process in the pharmaceutical industry
* Uniform and consistent interpretation of GMP complianceissues
* A review of the role of statistics and basic topics in analyticalchemistry
* An emphasis on high-performance liquid chromatographic (HPLC)methods
* Chapters on detectors and quantitative analysis as well as datasystems
* Methods for ensuring that instruments meet standard operatingprocedures (SOP) requirements
* Extensive appendixes for unifying terms, symbols, and proceduralinformation

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About the Author:

JAMES M. MILLER, PhD, is Emeritus Professor of Chemistry,Department of Chemistry, Drew University, Madison, NewJersey.
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services andSystems at the Janssen Research Foundation, a division of Johnson& Johnson.

Review:

"...chemists...explain how to comply with US Food and DrugAdministration's Good Manufacturing Practice rules as analyticaltechnologies are changing rapidly." (SciTech Book News, Vol.24, No. 4, December 2000)

"Anyone...involved in training exercises andin...gathering...pertinent material from different sources willfind this book very helpful." (Journal of MedicinalChemistry, Vol. 44, No. 21, 2001)

"I recommend this book for anyone who recognizes a need for moreand better training of pharmaceut9ical laboratory analysts...aremarkably rich resource." (Clinical Chemistry, Vol. 48, No.3, 2002)

"...provides a much needed perspective on the role of analyticalchemistry in the pharmaceutical industry and is a welcomeaddition...a useful resource." (Journal of ChemicalEducation, December 2002)

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Book Description John Wiley and Sons Ltd, United States, 2000. Hardback. Condition: New. 1. Auflage. Language: English. Brand new Book. 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. Seller Inventory # AAH9780471314318

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Book Description John Wiley and Sons Ltd, United States, 2000. Hardback. Condition: New. 1. Auflage. Language: English. Brand new Book. 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. Seller Inventory # AAH9780471314318

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