Biocontamination Control for Pharmaceuticals and Healthcare

1. Introduction<br>2. Sources of biocontamination, other forms of contamination, and risk profiling<br>3. GMP, regulations and standards<br>4. Biocontamination control<br>5. Application of Quality Risk Management and its application in biocontamination control<br>6. Introduction to cleanrooms and environmental monitoring<br>7. Viable monitoring methods<br>8. Selection of culture media<br>9. Airborne particle monitoring<br>10. Rapid microbiological methods11. Designing an environmental monitoring programme<br>11. Putting an environmental monitoring plan together: A risk-based case study<br>12. Special Types of Environmental Monitoring<br>13. Cleanrooms and microbiota<br>14. Assessment of pharmaceutical water systems<br>15. Data handling and trend analysi<br>16. Bioburden and endotoxin assessment of pharmaceutical processing<br>17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations<br>18. Assessing and removing contamination risks from the process<br>19. The human factor: Training and controlling people in cleanrooms<br>20. Biocontamination deviation management<br>21. Synthesis: An anatomy of a contamination control strategy