Über die Autorin bzw. den Autor

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.

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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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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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ANALYTICAL CHEMISTRY IN A GMP ENVIRONMENT

A Practical Guide

JOHN WILEY & SONS, INC.

Copyright © 2000 John Wiley & Sons, Inc.
All right reserved.
ISBN: 978-0-471-31431-8

Contents

CONTRIBUTORS..................................................................................................................................................................................xixFOREWORD......................................................................................................................................................................................xxiPREFACE.......................................................................................................................................................................................xxiii1 The Laboratory Analyst's Role in the Drug Development Process Jonathan B. Crowther, William Lauwers, Sagar Adusumalli, and Ponniah Shenbagamurthi..........................................12 Laboratory Controls and Compliance Henry Avallone..........................................................................................................................................313 The USP, ICH, and Other Compendial Methods Jennifer G. Feldman.............................................................................................................................494 Statistics in the Pharmaceutical Analysis Laboratory Alvin J. Melveger.....................................................................................................................775 Basic Analytical Operations and Solution Chemistry Nicholas H. Snow and Wyatt R. Murphy, Jr................................................................................................1056 Spectroscopy Perlette Abuaf and Alvin J. Melveger..........................................................................................................................................1497 Chromatographic Principles James M. Miller.................................................................................................................................................1858 Gas Chromatography James M. Miller and Harold M. McNair....................................................................................................................................2179 Liquid Chromatography: Basic Overview Lee N. Polite........................................................................................................................................25510 HPLC Column Parameters Richard Hartwick...................................................................................................................................................28311 Dissolution Ross Kirchhoefer and Rudy Peeters.............................................................................................................................................30912 Analytical Method Development for Assay and Impurity Determination in Drug Substances and Drug Products Jonathan B. Crowther, Paul Salomons, and Cindi Callaghan..........................33113 Some Principles of Quantitative Analysis James M. Miller..................................................................................................................................37114 Laboratory Data Systems R. D. McDowall....................................................................................................................................................39515 Qualification of Laboratory Instrumentation, Validation, and Transfer of Analytical Methods Jonathan B. Crowther, M. Ilias Jimidar, Nico Niemeijer, and Paul Salomons.....................423APPENDIXESI LIST OF SYMBOLS AND ACRONYMS................................................................................................................................................................459II GLOSSARY OF TERMS USED IN ICH DOCUMENTS....................................................................................................................................................467III UNIVERSAL TESTS, DOSAGE-FORM-SPECIFIC TESTS, AND ACCEPTANCE CRITERIA......................................................................................................................473IV USP CHROMATOGRAPHIC PHASES.................................................................................................................................................................477INDEX.........................................................................................................................................................................................483

Preface

In his Foreword and elsewhere, Layloff has described the need for more and better training of pharmaceutical laboratory analysts, as perceived by the Food and Drug Administration (FDA). To meet their own needs, the FDA produced a series of self-training aids that could be used in their testing laboratories. Many others are equally aware of the need for training because of the constant introduction of new methods, the increasing demands for better analyses, and the fact that little or no discussion of government regulations is presented in the traditional undergraduate educational program of chemists. Johnson & Johnson recognized this need in the spring of 1996 and began the development of an in-house training course. With the help of academic and industrial consultants, the course was first offered in October 1996 and became the basis for this text.

From the onset, the Johnson & Johnson Laboratory Analyst Training and Certification Program's (LATCP) objective has been to provide lecture and laboratory work in analytical chemical methods and in government regulations (CGMPs) and procedures. The two-week-long course has been presented over 20 times to over 300 analysts, selected from J&J sites around the world. A special facility was constructed for this purpose at the IRI Trials Management Center in New Jersey; more details on the program can be found in a recent trade publication.

This book is a natural outgrowth of the LATCP and is being published to make the contents of the program available more widely. The level of the material is that which has been found suitable for the participants in the course, who, on average, hold bachelor's degrees in chemistry and already have some experience in the pharmaceutical laboratory; these are typical recruitment criteria for J&J analysts.

The introductory chapter provides an orientation to the drug development process that might not be familiar to new employees in the pharmaceutical industry. Two chapters follow on regulations and compendia. Together these chapters should serve as a basis for understanding the issues in this regulated industry.

The middle chapters cover some basics of analytical chemistry of relevance to this audience, beginning with statistics and a quick review of equilibrium and solution chemistry. While this material may be too elementary for some, we have discovered that many students in our course are deficient in basic concepts such as significant figures, so such topics are included. The major quantitative techniques covered next are spectroscopy (UV and IR), chromatography (GC, LC, HPLC, and TLC), and dissolution. Of these, HPLC is unquestionably the most important and is the focus of much of the material throughout the book.

The final chapters cover detectors (mainly chromatographic), quantitative analysis, and data systems, plus the special topics of method development (based mainly on HPLC), qualification of instruments, and validation and method transfer.

A multiauthor work such as this one runs the risk of...