Good Manufacturing Practices for Pharmaceuticals
eBook - ePub

Good Manufacturing Practices for Pharmaceuticals

  1. 402 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Good Manufacturing Practices for Pharmaceuticals

About this book

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

Key Features

  • Presents insight into the world of pharmaceutical quality systems.
  • Analyzes regulatory trends and expectations.
  • Includes approaches and practices used in the industry to comply with regulatory requirements.
  • Discusses recent worldwide supply chain issues.
  • Delivers valuable information to a worldwide audience regarding the current Good Manufacturing Practices in the industry.

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Information

Publisher
CRC Press
Year
2026
eBook ISBN
9781040664940
Topic
Medicine
Subtopic
Business General

Table of contents

  1. Cover
  2. Half Title
  3. Series
  4. Title
  5. Copyright
  6. Contents
  7. Preface to the Eighth Edition
  8. About the Editor
  9. List of Contributors
  10. Chapter 1 Status and Applicability of US Regulations: CGMP
  11. Chapter 2 Quality Management Systems and Risk Management
  12. Chapter 3 Management Responsibility and Control
  13. Chapter 4 Organization and Personnel
  14. Chapter 5 Finished Pharmaceuticals: General Provisions
  15. Chapter 6 Production and Process Controls
  16. Chapter 7 Records and Reports
  17. Chapter 8 Clinical Trial Supplies
  18. Chapter 9 Contracting and Outsourcing
  19. Chapter 10 Buildings and Facilities
  20. Chapter 11 Equipment
  21. Chapter 12 Control of Components and Drug Product Containers and Closures
  22. Chapter 13 Holding and Distribution
  23. Chapter 14 Returned and Salvaged Drug Products
  24. Chapter 15 Active Pharmaceutical Ingredients
  25. Chapter 16 Pharmaceutical Excipient Good Manufacturing Practices
  26. Chapter 17 Packaging and Labeling Control
  27. Chapter 18 Laboratory Controls
  28. Chapter 19 FDA Inspections of 503A Compounding Pharmacies and 503B Outsourcing Facilities
  29. Chapter 20 CGMP Enforcement Alternatives in the United States
  30. Chapter 21 FDA Inspection Process
  31. Chapter 22 FDA Pre-Approval Inspections
  32. Chapter 23 Best Practices for the Pharmaceutical Industry: FDA Guidance on Refusing an Inspection
  33. Chapter 24 The Qualified Person in the Pharmaceutical Industry
  34. Chapter 25 Data Integrity and Fundamental Responsibilities
  35. Index

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Yes, you can access Good Manufacturing Practices for Pharmaceuticals by Graham P. Bunn in PDF and/or ePUB format, as well as other popular books in Medicine & Business General. We have over 1.5 million books available in our catalogue for you to explore.