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.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iii 6. Dedication - p. iii 7. Preface - p. xv 8. Chapter 1. Biocontamination control: Scope - p. 1 9. Chapter 2. Sources of biocontamination and risk profiling - p. 9 10. Chapter 3. GMP for contamination control: regulations and standards - p. 27 11. Chapter 4. Identifying the factors for biocontamination control - p. 49 12. Chapter 5. Application of quality risk management and its application in biocontamination control - p. 65 13. Chapter 6. Cleanrooms, controls and environmental monitoring - p. 115 14. Chapter 7. Viable monitoring methods - p. 159 15. Chapter 8. Selection of culture media - p. 179 16. Chapter 9. Airborne particle monitoring - p. 199 17. Chapter 10. Rapid and alternative microbiological methods - p. 219 18. Chapter 11. Designing an environmental monitoring program - p. 237 19. Chapter 12. Special types of environmental monitoring - p. 269 20. Chapter 13. Cleanrooms and microbiota - p. 287 21. Chapter 14. Assessment of pharmaceutical water systems - p. 313 22. Chapter 15. Data handling and trend analysis - p. 329 23. Chapter 16. Bioburden, endotoxin and virus hazards in pharmaceutical processing - p. 351 24. Chapter 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations - p. 365 25. Chapter 18. Assessing, minimizing and removing contamination risks from the process - p. 393 26. Chapter 19. The human factor: Training and controlling people in cleanrooms - p. 423 27. Chapter 20. Biocontamination deviation management and setting effective CAPA - p. 445 28. Chapter 21. Synthesis: An anatomy of a contamination control strategy - p. 475 29. Index - p. 481
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.
1. Title of Book - p. i 2. Cover image - p. i 3. Title page - p. ii 4. Table of Contents - p. iii 5. Copyright - p. iii 6. Dedication - p. iii 7. Preface - p. xv 8. Chapter 1. Biocontamination control: Scope - p. 1 9. Chapter 2. Sources of biocontamination and risk profiling - p. 9 10. Chapter 3. GMP for contamination control: regulations and standards - p. 27 11. Chapter 4. Identifying the factors for biocontamination control - p. 49 12. Chapter 5. Application of quality risk management and its application in biocontamination control - p. 65 13. Chapter 6. Cleanrooms, controls and environmental monitoring - p. 115 14. Chapter 7. Viable monitoring methods - p. 159 15. Chapter 8. Selection of culture media - p. 179 16. Chapter 9. Airborne particle monitoring - p. 199 17. Chapter 10. Rapid and alternative microbiological methods - p. 219 18. Chapter 11. Designing an environmental monitoring program - p. 237 19. Chapter 12. Special types of environmental monitoring - p. 269 20. Chapter 13. Cleanrooms and microbiota - p. 287 21. Chapter 14. Assessment of pharmaceutical water systems - p. 313 22. Chapter 15. Data handling and trend analysis - p. 329 23. Chapter 16. Bioburden, endotoxin and virus hazards in pharmaceutical processing - p. 351 24. Chapter 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations - p. 365 25. Chapter 18. Assessing, minimizing and removing contamination risks from the process - p. 393 26. Chapter 19. The human factor: Training and controlling people in cleanrooms - p. 423 27. Chapter 20. Biocontamination deviation management and setting effective CAPA - p. 445 28. Chapter 21. Synthesis: An anatomy of a contamination control strategy - p. 475 29. Index - p. 481
