Analytical Chemistry in a GMP Environment: A Practical Guide

by James M. Miller (Editor)

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

512 pages, Hardcover

First published April 17, 2000

Reviews

[Erochlis · Rating 4 out of 5]

Dr. Miller and Dr. McNair are good at what they teach. Its everything that you didn't really care to learn about analytical chemistry, but had to because your job is all about GMP and instrumentation. A good resource for those who's careers have landed them in the lab.

[Carlos · Rating 3 out of 5]

This book came into my hands thanks to a work colleague and I have to admit that it has become the only chemistry book, so far, that I have kept as a reference book at work. The authors are very aware that the average chemistry bachelor’s degree does not dwell enough in the knowledge that a laboratory analyst will require and they set out to fill in those gaps. The book is then composed of quick overviews of the chemical theory needed for lab work with a much more extensive discussion on the practical aspects of work in the pharmaceutical industry. It also deals with all the different aspect of laboratory work, from formulation to method development, which makes it a great resource for those of us beginning our careers in this industry. I can honestly say that it is the most useful chemistry book I’ve ever read.