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Analytical Chemistry in a GMP Environment: A Practical Guide. James M. Miller and Jonathan B. Crowther, eds. New York: John Wiley & Sons, 2000, 509 pp., $115.00, hardcover. ISBN 0-471-31431-5.

¹ University of Houston, Houston, TX 77004

I like this book. It grew out of "a need for more and better training of pharmaceutical laboratory analysts, as perceived by the Food and Drug Administration". In the spring of 1996, Johnson & Johnson began the development of a two-week, in-house training course to meet this need. That course became the basis for this book.

The 15 chapters are contributed by 21 authors, 17 from industry (Janssen is well represented with 10 authors), and four from academia (Harold McNair of Virginia Tech, James M. Miller of Drew University, and W. Rorer Murphy and Nicholas H. Snow at Seton Hall). The editors have also contributed heavily to the book, authoring or coauthoring three chapters each, none with each other.

From the beginning, the focus is on the analyst: "The Laboratory Analyst’s Role in the Drug Development Process" sets the tone for the remaining chapters in the book. "Laboratory Controls and Compliance" gives further perspective on the regulated environment in which pharmaceutical analysts work. Specific requirements are discussed in Chapter 3, "The USP, ICH, and Other Compendial Methods".

The next two chapters provide general information about "Statistics in the Pharmaceutical Analysis Laboratory" and "Basic Analytical Operations and Solution Chemistry" (including electrochemical measurements). More advanced "Principles of Quantitative Analysis" (e.g., internal standards and external standards) are covered later in Chapter 13. These three chapters are models of conciseness and clarity, allowing the reader to cover with understanding a broad range of traditional "quantitative analysis" material. Spectroscopy is discussed in Chapter 6. Separations are presented Chapters 7–10: "Chromatographic Principles", "Gas Chromatography", "Liquid Chromatography: Basic Overview", and "HPLC Column Parameters". Chapter 11 covers the important topic of "Dissolution". Chapter 14 addresses "Laboratory Data Systems".

The remaining chapters (12 and 15) are (for me) the meat of this book. They cover the broader aspects of "Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products" and "Quantification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods". The perspective offered by these two chapters is invaluable.

I recommend this book for anyone who recognizes a need for more and better training of pharmaceutical laboratory analysts, either for self-study or in conjunction with a course. The book is a remarkably rich resource.

This Article Extract Full Text (PDF) Submit an electronic Letter to the Editor about this paper Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Deming, S. N. Search for Related Content PubMed Articles by Deming, S. N.