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Analytical Chemistry in a GMP Environment: A Practical Guide | 
 enlarge | Author: Jim Miller
Creators: James M. Miller, Jonathan B. Crowther
Publisher: Wiley-Interscience
Category: Book
List Price: $175.00
Buy New: $140.00
You Save: $35.00 (20%)
New (12) Used (8) from $122.60
Rating:  1 reviews
Sales Rank: 639660
Media: Hardcover
Edition: 1
Pages: 488
Number Of Items: 1
Shipping Weight (lbs): 1.9
Dimensions (in): 9.7 x 6.3 x 1.1
ISBN: 0471314315
Dewey Decimal Number: 615.190685
EAN: 9780471314318
ASIN: 0471314315
Publication Date: April 17, 2000
Availability: Usually ships in 24 hours
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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
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| Customer Reviews:
A "real" practical book July 1, 2004
Sanjay Sharma (NJ, USA)
4 out of 4 found this review helpful
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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