PDA DHI Technical Books

Pharmaceutical Quality

Edited by: Richard Prince

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.

Below chapters are now available to purchase as an individual booklet:

  • Quality Management in the American Pharmaceutical Industry,
    by Richard L. Friedman

  • Using Statistics to Measure and Improve Quality,
    by Lynn D. Torbeck

  • Training and Learning: Critical Contributors to Quality,
    by James L. Vesper


  • Table of Contents:
    Click here to download >>> 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 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.


    Date of Publication: July 2004
    ISBN Number: 1930114613
    Format:
    Number of Pages: 758
    Binding: Hardcover