Pharmaceutical Quality (Hardcover)
- Published
- Jul 2004
- ISBN
- 1930114613
- Pages
- 758
- PDA Item Number
- 17207
- Format
- Book
- Member Price
- $225.00
- Nonmember Price
- $280.00
- Government Price
- $150.00
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Pharmaceutical Quality is a collection of essays that offer an examination of quality from the perspectives of senior experts working in industry, government and academia from around the world. Pharmaceutical Quality enriches our recognition of what quality is, or what we think it is.
I. Section One includes ten chapters that present international and national systems (and perspectives) of quality from Australia, Britain, Canada, Germany, Israel, Japan and Singapore as well as the United States.
II. The second section of the book focuses on industrial quality systematics, the interplay of quality systems in commercial pharmaceutical manufacturing.
III. The third and final section of the book provides perspectives on quality from industry though leaders.
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Table of Contents
Table of Contents:
Click here to
download >>> Detailed Table of Contents
Introduction - Richard Prince
SECTION I: THE INTERNATIONAL
LANDSCAPE OF QUALITY
(Click here to download >>>Chapter 1)
1. Global Disequilibrium of Quality -
Lembit Rägo
2. Good Manufacturing Practices: An International
Perspective - Michael H. Anisfeld
3. Quality Management in the
American Pharmaceutical Industry - Richard L. Friedman
4. The
Australian System of Quality for Medicines and Other Therapeutic Products -
Paul K. Priscott
5. Quality Assurance of Healthcare Products in the
United Kingdom - John L. Turner
6. Canada`s National Healthcare System
of Quality - Suzanne Levesque, Pierre Morin and Leonor Ferreira
7.
Germany`s National Quality System for Healthcare Products - Günter Winkmann
and Harald G. Schweim
8. Israeli System of Quality: Emphasis on Medicines
- Karen Ginsbury
9. Japanese National System of Quality: Emphasis on
Medicines - Kunio Kawamura, Katutoshi Mise and Sadayoshi Tomita
10.
Singapore`s National Healthcare System of Quality - Teng-Heng Chan and
Hesan-Ahmad Quazi
SECTION II: INDUSTRIAL QUALITY SYSTEMATICS: THE
INTERPLAY OF QUALITY SYSTEMS IN COMMERCIAL MANUFACTURING
11. Quality
Systems and Pharmaceutical cGMP Compliance - William S. Hitchings
12.
Quality Systematics for Contract Service Users - Diane M. Petitti
13.
Quality for Computerized Systems and Electronic Data in Regulated Environments -
Teri Stokes
14. Quality Control of Pharmaceutical and Biological
Products - Effie Michalopoulos
15. Using Statistics to Measure and
Improve Quality - Lynn D. Torbeck
16. Pharmaceutical Quality Auditing
- Mary Moriva and Steve Iland
SECTION III: PERSPECTIVES ON
QUALITY
17. Industrial Quality for the Start-Up Biotech Company -
Steven S. Kuwahara
18. Quality at the Threshold of Enforcement:
Perspectives from Industry and FDA - Gregory Bobrowicz
19. Training
and Learning: Critical Contributors to Quality - James L. Vesper
20.
Quality Management for Legal/Regulatory Programs - Gary
Gamerman
Index
About the Authors
About the Editor
Dr. Richard
Prince founded or co -founded a series of companies (i.e.,
microbiology-quality systems consultancy; disinfectants firm; and
education-placement bioscience firm). He received his BA (in Microbiology) and
PhD (with a focus on tumor immunology) from Rutgers University. Dr. Prince
currently consults for the biopharmaceutical industry. In addition to being the
developmental editor of Microbiology in Pharmaceutical
Manufacturing.a best-selling textbook, he also is the
developmental editor of this textbook, Pharmaceutical
Quality.