#1. Pre-operational sanitation is best described as:
#2. Why is a newly installed pharmaceutical water system not considered clean by default?
#3. Which activity must always precede disinfection?
#4. The primary risk of skipping pre-operational sanitation is:
#5. Which contaminant is most likely introduced during system fabrication?
#6. What is the main purpose of initial flushing?
#7. Chemical cleaning primarily targets:
#8. Why is rinsing critical after chemical cleaning?
#9. Which parameter is NOT typically controlled during chemical cleaning?
#10. Thermal sanitization controls microorganisms mainly by:
#11. Which disinfectant leaves no chemical residue when properly applied?
#12. System drainability is important because it:
#13. What does “system stabilization” indicate?
#14. Which test is most relevant immediately after pre-operational sanitation?
#15. Pre-operational sanitation is typically performed: A. After PQ
#16. Why is pre-operational sanitation considered a preventive control?
#17. Which document provides step-by-step sanitation instructions?
#18. A failure in pre-operational sanitation is MOST likely to result in:
#19. Why are sampling points important during sanitation verification?
#20. Which statement best summarizes pre-operational sanitation?
#21. What happens if cleaning residues remain after rinsing?
#22. Which phase focuses on microbiological “reset”?
#23. Pre-operational sanitation demonstrates:
#24. Which utility system requires the highest sanitation stringency?
#25. The long-term benefit of proper pre-operational sanitation is:
#26. During an audit, which observation would MOST strongly indicate inadequate pre-operational sanitation?
#27. Which documentation gap represents a critical GMP risk during pre-operational sanitation review?
#28. A water system shows acceptable results during PQ but frequent failures afterward. From an audit perspective, the MOST likely root cause is:
#29. Which parameter is MOST critical for demonstrating effective chemical cleaning during pre-operational sanitation?
#30. Why is drainability verification considered an audit-critical activity before sanitation?
MCQ for Pre-Operational Sanitation of Pharmaceutical Water Purification System
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