Analytical Chemistry in a Gmp Environment: A Practical Guide

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9780471314318: Analytical Chemistry in a Gmp Environment: A Practical Guide

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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Editore: John Wiley and Sons Ltd, United States (2000)
ISBN 10: 0471314315 ISBN 13: 9780471314318
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Descrizione libro John Wiley and Sons Ltd, United States, 2000. Hardback. Condizione libro: New. 1. Auflage. 234 x 157 mm. 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. Codice libro della libreria AAH9780471314318

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Editore: John Wiley and Sons Ltd, United States (2000)
ISBN 10: 0471314315 ISBN 13: 9780471314318
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Descrizione libro John Wiley and Sons Ltd, United States, 2000. Hardback. Condizione libro: New. 1. Auflage. 234 x 157 mm. 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. Codice libro della libreria AAH9780471314318

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Miller, Jim
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Descrizione libro Wiley-Interscience, 2000. Hardcover. Condizione libro: New. book. Codice libro della libreria 0471314315

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Descrizione libro Wileyand#8211;Blackwell, 2000. HRD. Condizione libro: New. New Book. Shipped from UK in 4 to 14 days. Established seller since 2000. Codice libro della libreria FW-9780471314318

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Descrizione libro John Wiley and Sons Ltd. Hardback. Condizione libro: new. BRAND NEW PRINT ON DEMAND., Analytical Chemistry in a GMP Environment: A Practical Guide, James M. Miller, Jonathan B. Crowther, 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. Codice libro della libreria B9780471314318

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Jim Miller, James M. Miller (Editor), Jonathan B. Crowther (Editor)
Editore: Wiley-Interscience (2000)
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Descrizione libro Wiley-Interscience, 2000. Hardcover. Condizione libro: New. 1. Codice libro della libreria DADAX0471314315

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Descrizione libro Wiley-Interscience, 2000. Condizione libro: New. Brand New, Unread Copy in Perfect Condition. A+ Customer Service! Summary: The Laboratory Analyst's Role in the Drug Development Process (J. Crowther, et al.). Laboratory Controls and Compliance (H. Avallone). The USP, ICH, and Other Compendial Methods (J. Feldman). Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger). Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy). Spectroscopy (P. Abauf & A. Melveger). Chromatographic Principles (J. Miller). Gas Chromatography (J. Miller & H. McNair). Liquid Chromatography: Basic Overview (L. Polite). HPLC Column Parameters (R. Hartwick). Dissolution (R. Kirchhoefer & R. Peeters). Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.). Some Principles of Quantitative Analysis (J. Miller). Laboratory Data Systems (R. McDowall). Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.). Appendices. Index. Codice libro della libreria ABE_book_new_0471314315

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Descrizione libro 2000. Hardcover. Condizione libro: New. 1st. 161mm x 29mm x 245mm. Hardcover. 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 .Shipping may be from multiple locations in the US or from the UK, depending on stock availability. 512 pages. 0.839. Codice libro della libreria 9780471314318

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Descrizione libro Wileyand#8211;Blackwell, 2000. HRD. Condizione libro: New. New Book.Shipped from US within 10 to 14 business days.THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Codice libro della libreria IP-9780471314318

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Descrizione libro John Wiley & Sons, 2016. Paperback. Condizione libro: New. PRINT ON DEMAND Book; New; Publication Year 2016; Not Signed; Fast Shipping from the UK. No. book. Codice libro della libreria ria9780471314318_lsuk

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