Analytical Chemistry in a GMP Environment: A Practical Guide

ISBN-13: 9780471314318 / Angielski / Twarda / 2000 / 512 str.

James M. Miller; Jonathan B. Crowther

Opis

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

Recenzje

"...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)

Spis treści

The Laboratory Analyst′s Role in the Drug Development Process (J. Crowther, et al.).

Laboratory Controls and Compliance (H. Avallone).

The USP, ICH, and Other Compendial Methods (J. Feldman).

Statistics in the Pharmaceutical Analysis Laboratory (A. Melveger).

Basic Analytical Operations and Solution Chemistry (N. Snow & W. Murphy).

Spectroscopy (P. Abauf & A. Melveger).

Chromatographic Principles (J. Miller).

Gas Chromatography (J. Miller & H. McNair).

Liquid Chromatography: Basic Overview (L. Polite).

HPLC Column Parameters (R. Hartwick).

Dissolution (R. Kirchhoefer & R. Peeters).

Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products (J. Crowther, et al.).

Some Principles of Quantitative Analysis (J. Miller).

Laboratory Data Systems (R. McDowall).

Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods (J. Crowther, et al.).

Appendices.

Index.

O autorze

JAMES M. MILLER, PhD, is Emeritus Professor of Chemistry, Department of Chemistry, Drew University, Madison, New Jersey.
JONATHAN B. CROWTHER, PhD, is Director of Analytical Services and Systems at the Janssen Research Foundation, a division of Johnson & Johnson.