Analytical Chemistry in a GMP Environment

Der zunehmende Druck des Gesetzgebers auf die pharmazeutische Industrie steigert die Nachfrage nach Fachkräften, die in Forschung, Entwicklung und Produktion zuverlässig und qualitätssicher arbeiten. Dieser Band ging aus dem einschlägigen Inhouse-Weiterbildungsprogramm von Johnson&Johnson hervor und zeigt dem Analytiker anschaulich, wie die GMP-Vorschriften der FDA im Alltag umzusetzen sind. Angesprochen werden alle wichtigen Analysenverfahren und Methoden, von der Spektroskopie über die Chromatographie bis zur Herstellung von Lösungen. Hervorragend auch zum Selbststudium geeignet!

Zusatztext "...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) Informationen zum 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. Klappentext How to hone your analytical skills and obtain high-quality data in the era of GMP requirementsWith 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 Zusammenfassung Der zunehmende Druck des Gesetzgebers auf die pharmazeutische Industrie steigert die Nachfrage nach Fachkräften, die in Forschung, Entwicklung und Produktion zuverlässig und qualitätssicher arbeiten. Dieser Band ging aus dem einschlägigen Inhouse-Weiterbildungsprogramm von Johnson&Johnson hervor und zeigt dem Analytiker anschaulich, wie die GMP-Vorschriften der FDA im Alltag umzusetzen sind. Angesprochen werden alle wichtigen Analysenverfahren und Methoden, von der Spektroskopie über die Chromatographie bis zur Herstellung von Lösungen. Hervorragend auch zum Selbststudium geeignet! (09/00) Inhaltsverzeichnis 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...

Auteur
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.

Texte du rabat
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

Contenu

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.