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. Includes the most current regulationsContains 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 StrategyOffers practical guidance on building a complete biocontamination strategy INDICE: 1. Introduction2. Sources of biocontamination, other forms of contamination, and risk profiling3. GMP, regulations and standards4. Biocontamination control5. Application of Quality Risk Management and its application in biocontamination control6. Introduction to cleanrooms and environmental monitoring7. Viable monitoring methods8. Selection of culture media9. Airborne particle monitoring10. Rapid microbiological methods11. Designing an environmental monitoring programme11. Putting an environmental monitoring plan together: A risk-based case study12. Special Types of Environmental Monitoring13. Cleanrooms and microbiota14. Assessment of pharmaceutical water systems15. Data handling and trend analysi16. Bioburden and endotoxin assessment of pharmaceutical processing17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations18. Assessing and removing contamination risks from the process19. The human factor: Training and controlling people in cleanrooms20. Biocontamination deviation management21. Synthesis: An anatomy of a contamination control strategy
- ISBN: 978-0-443-21600-8
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 508
- Fecha Publicación: 16/02/2024
- Nº Volúmenes: 1
- Idioma: Inglés