Good Pharmaceutical Manufacturing Practice
eBook - ePub

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

  1. 520 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Good Pharmaceutical Manufacturing Practice

Rationale and Compliance

About this book

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceuti

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Yes, you can access Good Pharmaceutical Manufacturing Practice by John Sharp in PDF and/or ePUB format, as well as other popular books in Medicine & Chemistry. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2004
Print ISBN
9780849319945
eBook ISBN
9781135492397
Topic
Medicine
Subtopic
Chemistry
Index
Chemistry

Table of contents

  1. Cover
  2. Half Title
  3. Title Page
  4. Copyright Page
  5. Preface
  6. The Author
  7. Table Of Contents
  8. Chapter 1 Intr oduction: Status and Applicability of US Regulations/ EU Guidelines — General Quality Issues
  9. Chapter 2   Personnel, Or ganization, and T raining
  10. Chapter 3    Premises/Buildings and Facilities
  11. Chapter 4Contamination and Contamination Contr ol
  12. Chapter 5   Equipment
  13. Chapter 6   Materials Contr ol
  14. Chapter 7   Production and Pr ocess Contr ols
  15. Chapter 8   Packaging and Labeling Contr ol
  16. Chapter 9   Holding and Distribution
  17. Chapter 10  Laboratory Contr ols
  18. Chapter 11  Recor ds and Reports
  19. Chapter 12  Retur ned and Salvaged Drug Pr oducts
  20. Chapter 13  Sterile Pr oducts Manufactur e — Basic Principles
  21. Chapter 14 GMP and Quality Assurance in Sterile Pr oducts Manufactur e
  22. Chapter 15 Validation — General Principles
  23. Chapter 16  Validation — Applications
  24. Chapter 17  Self-Inspection and Quality Audit
  25. Chapter 18 US cGMPs and EC GMP Guide — Concluding Comparison