Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition 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 covers 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), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between…mehr
Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition 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 covers 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), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation. This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.
Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University. He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation. Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university's pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).
Inhaltsangabe
1. Introduction 2. Sources of biocontamination, other forms of contamination, and risk profiling 3. GMP, regulations and standards 4. Biocontamination control 5. Application of Quality Risk Management and its application in biocontamination control 6. Introduction to cleanrooms and environmental monitoring 7. Viable monitoring methods 8. Selection of culture media 9. Airborne particle monitoring 10. Rapid microbiological methods11. Designing an environmental monitoring programme 11. Putting an environmental monitoring plan together: A risk-based case study 12. Special Types of Environmental Monitoring 13. Cleanrooms and microbiota 14. Assessment of pharmaceutical water systems 15. Data handling and trend analysi 16. Bioburden and endotoxin assessment of pharmaceutical processing 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations 18. Assessing and removing contamination risks from the process 19. The human factor: Training and controlling people in cleanrooms 20. Biocontamination deviation management 21. Synthesis: An anatomy of a contamination control strategy
1. Introduction 2. Sources of biocontamination, other forms of contamination, and risk profiling 3. GMP, regulations and standards 4. Biocontamination control 5. Application of Quality Risk Management and its application in biocontamination control 6. Introduction to cleanrooms and environmental monitoring 7. Viable monitoring methods 8. Selection of culture media 9. Airborne particle monitoring 10. Rapid microbiological methods11. Designing an environmental monitoring programme 11. Putting an environmental monitoring plan together: A risk-based case study 12. Special Types of Environmental Monitoring 13. Cleanrooms and microbiota 14. Assessment of pharmaceutical water systems 15. Data handling and trend analysi 16. Bioburden and endotoxin assessment of pharmaceutical processing 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations 18. Assessing and removing contamination risks from the process 19. The human factor: Training and controlling people in cleanrooms 20. Biocontamination deviation management 21. Synthesis: An anatomy of a contamination control strategy
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