Biocontamination Control for Pharmaceuticals and Healthcare
eBook - ePub
Available until 21 Sep |Learn more

Biocontamination Control for Pharmaceuticals and Healthcare

  1. 400 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub
Available until 21 Sep |Learn more

Biocontamination Control for Pharmaceuticals and Healthcare

Book details
Table of contents
Citations

About This Book

Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility.

The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation.

Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

  • Includes the most current regulations
  • Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy
  • Offers practical guidance on building a complete biocontamination strategy

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Yes, you can access Biocontamination Control for Pharmaceuticals and Healthcare by Tim Sandle in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Academic Press
Year
2024
ISBN
9780443216015
Edition
2
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Cover image
  2. Title page
  3. Table of Contents
  4. Copyright
  5. Dedication
  6. Preface
  7. Chapter 1. Biocontamination control: Scope
  8. Chapter 2. Sources of biocontamination and risk profiling
  9. Chapter 3. GMP for contamination control: regulations and standards
  10. Chapter 4. Identifying the factors for biocontamination control
  11. Chapter 5. Application of quality risk management and its application in biocontamination control
  12. Chapter 6. Cleanrooms, controls and environmental monitoring
  13. Chapter 7. Viable monitoring methods
  14. Chapter 8. Selection of culture media
  15. Chapter 9. Airborne particle monitoring
  16. Chapter 10. Rapid and alternative microbiological methods
  17. Chapter 11. Designing an environmental monitoring program
  18. Chapter 12. Special types of environmental monitoring
  19. Chapter 13. Cleanrooms and microbiota
  20. Chapter 14. Assessment of pharmaceutical water systems
  21. Chapter 15. Data handling and trend analysis
  22. Chapter 16. Bioburden, endotoxin and virus hazards in pharmaceutical processing
  23. Chapter 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations
  24. Chapter 18. Assessing, minimizing and removing contamination risks from the process
  25. Chapter 19. The human factor: Training and controlling people in cleanrooms
  26. Chapter 20. Biocontamination deviation management and setting effective CAPA
  27. Chapter 21. Synthesis: An anatomy of a contamination control strategy
  28. Index