The Certified Pharmaceutical GMP Professional Handbook
eBook - PDF
Available until 23 Dec |Learn more

The Certified Pharmaceutical GMP Professional Handbook

  1. 516 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF
Available until 23 Dec |Learn more

The Certified Pharmaceutical GMP Professional Handbook

About this book

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight.This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

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Yes, you can access The Certified Pharmaceutical GMP Professional Handbook by Mark Allen Durivage in PDF and/or ePUB format, as well as other popular books in Business & Pharmaceutical, Biotechnology & Healthcare Industry. We have over one million books available in our catalogue for you to explore.

Table of contents

  1. Cover
  2. Title Page
  3. CIP Data
  4. Table of Contents
  5. List of Figures and Tables
  6. Acronyms and Abbreviations
  7. Preface
  8. Acknowledgments
  9. Part I: Regulatory Agency Governance
  10. Part II: Quality Systems
  11. Part III: Laboratory Systems
  12. Part IV: Infrastructure: Facilities, Utilities, Equipment
  13. Part V: Materials Management and Supply Chain
  14. Part VI: Sterile and Nonsterile Manufacturing Systems
  15. Part VII: Filling, Packaging, Labeling
  16. Part VIII: Product Development and Technology Transfer
  17. Appendix A: At-a-Glance Comparisons
  18. Appendix B: 21 CFR 211 Pharmaceuticals GMP Overview
  19. Appendix C: 21 CFR 820 Medical Device GMP Overview
  20. Appendix D: Body of Knowledge—Pharmaceutical GMP Professional Certification (CPGP)
  21. Glossary
  22. References and Suggested Reading
  23. Index