Analytical Chemistry in a GMP Environment: A Practical Guide by Jim Miller, James M. Miller and Jonathan B. Crowther 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. This text shows 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. An ideal manual for formal training as well as an excellent self-study guide, this book features the drug development process in the pharmaceutical industry, uniform and consistent interpretation of GMP compliance issues, review of the role of statistics and basic topics in analytical chemistry and emphasis on high-performance liquid chromatographic (HPLC) methods.
There are chapters on detectors and quantitative analysis as well as data systems, methods for ensuring that instruments meet standard operating procedures (SOP) requirements and extensive appendixes for unifying terms, symbols, and procedural information. I recommend this book for anyone who recognizes a need for more and better training of pharmaceutical laboratory analysts.
This text provides a much needed perspective on the role of analytical chemistry in the pharmaceutical industry and is a welcome addition. The book focuses on technical and practical aspects faced by chemists working in the analytical lab. The book is written with an approach to achieve GMP compliance. All chapters have been written by area experts making it very useful and comprehensive.
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