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Analytical Chemistry in a GMP Environment: A Practical Guide [Hardcover]

James M. Miller , Jonathan B. Crowther
5.0 out of 5 stars  See all reviews (1 customer review)
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Book Description

May 1 2000 0471314315 978-0471314318 1
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

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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)

"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)

From the Back Cover

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

Inside This Book (Learn More)
First Sentence
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 chapter attempts to review analytical methodology used during the drug development process. Read the first page
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Front Cover | Copyright | Table of Contents | Excerpt | Index | Back Cover
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Most helpful customer reviews
5.0 out of 5 stars A "real" practical book June 30 2004
Format:Hardcover
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.
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Amazon.com: 5.0 out of 5 stars  2 reviews
4 of 4 people found the following review helpful
5.0 out of 5 stars A "real" practical book June 30 2004
By Sincerely yours - Published on Amazon.com
Format:Hardcover
This is the book if you work in the analytical lab of pharmaceutical industry. The book focuses on technical and practicals 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. I strongly recommend this book.
5.0 out of 5 stars Excellent Feb. 5 2013
By Ida Know - Published on Amazon.com
Format:Hardcover|Verified Purchase
This is an excellent reference for any scientist at any level. There are days that you are burnt out and your analytical reasoning has failed. This book helps a lot.
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