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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)
Price: 140.00 & FREE Delivery in the UK. Details
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Book Description

15 May 2000 Chemistry
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

Product details

  • Hardcover: 512 pages
  • Publisher: Wiley-Blackwell; 1 edition (15 May 2000)
  • Language: English
  • ISBN-10: 0471314315
  • ISBN-13: 978-0471314318
  • Product Dimensions: 25 x 16 x 3 cm
  • Average Customer Review: 5.0 out of 5 stars  See all reviews (1 customer review)
  • Amazon Bestsellers Rank: 253,876 in Books (See Top 100 in Books)
  • See Complete Table of Contents

Product Description

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
0 of 1 people found the following review helpful
5.0 out of 5 stars No More Laboratory 483 Points 24 Mar 2004
Format:Hardcover
This is a brilliant book, which Thomas Layloff of the FDA writes the forward for. Writing with passion - based on his experience of FDA audits, it is a "chilling" forward, where Layloff once again raises his strong concerns over Knowledge, Skills and Abilities of Managers and Analysts in the Pharmaceutical Industry (i.e. TRAINING).
Thankfully, the book was written to address these concerns. In the forward, Layloff writes that the book helps:-
"establish a basic knowledge and skill base in the technologies that are most prevalent in "Product Control Laboratories" of the Pharmaceutical Industry"
(Note:- remember, this is Layloff's definition of basic, chapters are written by industry experts !!!)
For Managers of Laboratories, particularly those in the Pharmaceutical Industry, there should be no real surprises in this book - the information presented is not rocket science. However, digest and implement the information in this book and your lab. will be a long way towards passing an FDA or MCA inspection !!
The qualities of the book lie in the simplicity and accuracy of the presentation, layout (with good contents and indexes), structure and intelligent discussion of issues. It stops just short of telling you "exactly" what to do, but all the issues are frankly discussed (e.g. HPLC column equivalency), which goes a long way to really understanding what is required.
If you work in the Pharmaceutical Industry - Buy This Book !.
If not, read on - the analytical science makes it a very good reference source for training information. Instrumentation, Equipment Validation (DQ to PQ), Method Validation and Analytical Method transfer are all covered.
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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 1 July 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 5 Feb 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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