Analytical Chemistry in a GMP Environment: A Practical Guide (Hardcover)

by James M. Miller (Editor), Jonathan B. Crowther (Editor), Jim Miller (Author) "While many chapters in this text will focus on analytical methods used in release and stability of marketed drug substance and drug products, this initial..." (more)
Key Phrases: method development report, method development scientist, analytical method transfer, New York, John Wiley, United States Pharmacopeia (more...)

Editorial Reviews

Review
"...chemists...explain how to comply with US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly." -- SciTech Book News, Vol. 24, No. 4, December 2000

"...chemists...explain how to comply with US Food and Drug Administration's Good Manufacturing Practice rules as analytical technologies are changing rapidly." (SciTech Book News, Vol. 24, No. 4, December 2000)

"Anyone...involved in training exercises and in...gathering...pertinent material from different sources will find this book very helpful." (Journal of Medicinal Chemistry, Vol. 44, No. 21, 2001)

"I recommend this book for anyone who recognizes a need for more and better training of pharmaceut9ical laboratory analysts...a remarkably rich resource." (Clinical Chemistry, Vol. 48, No. 3, 2002)

"...provides a much needed perspective on the role of analytical chemistry in the pharmaceutical industry and is a welcome addition...a useful resource." (Journal of Chemical Education, December 2002)

"Anyone...involved in training exercises and in...gathering...pertinent material from different sources will find this book very helpful." -- Journal of Medicinal Chemistry, Vol. 44, No. 21, 2001

"I recommend this book for anyone who recognizes a need for more and better training of pharmaceutical laboratory analysts..." -- Clinical Chemistry, Vol. 48, No. 3, 2002

Product Description
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

See all Editorial Reviews

Product Details

• Hardcover: 488 pages
• Publisher: Wiley-Interscience; 1 edition (April 17, 2000)
• Language: English
• ISBN-10: 0471314315
• ISBN-13: 978-0471314318
• Product Dimensions: 9.7 x 6.3 x 1.1 inches
• Shipping Weight: 1.8 pounds (View shipping rates and policies)
• Average Customer Review: 5.0 out of 5 stars See all reviews (1 customer review)
• Amazon.com Sales Rank: #478,722 in Books (See Bestsellers in Books)

  Popular in this category: (What's this?)

  #9 in

  Books > Professional & Technical > Medical > Pharmacology > Chemistry

Customer Reviews

Most Helpful Customer Reviews

4 of 4 people found the following review helpful:

5.0 out of 5 stars A "real" practical book, June 30, 2004

By	Sanjay Sharma (NJ, USA) - See all my reviews

This is the book if you work in the analytical lab of pharmaceutical industry. The book covers a lot of practical and day to day problems faced by persons working in the analytical lab especially from a regulatory point of view. Different chapters have been written by area experts making it very useful and comprehensive. I strongly recommend this book.