Analytical Chemistry in a GMP Environment: A Practical Guide
Language: English
Published by Wiley-Interscience, 2000
- Hardcover
- Used
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- Title
- Analytical Chemistry in a GMP Environment: A Practical Guide
- Publisher
- Wiley-Interscience
- Publication year
- 2000
- Condition
- acceptable
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 0471314315
- ISBN 13
- 9780471314318
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
"Synopsis" may belong to another edition of this title.
About the Author
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services and Systems at the Janssen Research Foundation, a division of Johnson & Johnson.
"About the title" may belong to another edition of this title.
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