ANALYTICAL CHEMISTRY IN A GMP ENVIRONMENT A Practical Guide

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 worl...

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Bibliographic Details
Other Authors: Crowther, Jonathan B. (edited), Miller, James M. (edited)
Format: Book
Language:English
Published: New York John Wiley & Sons 2000
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Online Access:Click Here to View Status and Holdings.
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520 # # |a 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. 
650 # 0 |a Chemistry, Pharmaceutical  |x education 
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650 # 0 |a Technology, Pharmaceutical 
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700 1 # |a Miller, James M.  |e edited 
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