Analytical Chemistry in a GMP Environment: A Practical Guide

How to hone your analytical skills and obtain high-quality data inthe era of GMP requirements
With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensureappropriate scientific practices in laboratories and manufacturingsites worldwide. Based on Johnson & Johnson's acclaimedin-house training program, this practical guide provides guidancefor laboratory analysts who must juggle the Food and DrugAdministration's good manufacturing practices (GMP) rules withrapidly changing analytical technologies. Highly qualified industryexperts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulatedenvironment, including clear instructions on all major analyticalchemical methods-from spectroscopy to chromatography todissolution. An ideal manual for formal training as well as anexcellent self-study guide, Analytical Chemistry in a GMPEnvironment features:
* The drug development process in the pharmaceutical industry
* Uniform and consistent interpretation of GMP complianceissues
* A review of the role of statistics and basic topics in analyticalchemistry
* An emphasis on high-performance liquid chromatographic (HPLC)methods
* Chapters on detectors and quantitative analysis as well as datasystems
* Methods for ensuring that instruments meet standard operatingprocedures (SOP) requirements
* Extensive appendixes for unifying terms, symbols, and proceduralinformation