Environmental Monitoring – Total Particle Monitoring EUGMP- Annex-1
Questions 1. A total particle monitoring program should be established to:
A. Reduce batch sizes
B. Assess contamination risks and maintain sterile environments
C. Replace viable monitoring
D. Evaluate operator performance
Answer: B
Questions 2. Environmental monitoring limits for Grade D in operation are:
A. Fixed by regulation
B. Not predetermined
C. Same as Grade A
D. Always zero
Answer: B
Questions 3. Grade D operational limits should be established based on:
A. Cost
B. Operator opinion
C. Risk assessment and routine data
D. Supplier recommendations
Answer: C
Questions 4. “At rest” particle limits should be achieved after:
A. 1 hour clean-up
B. A long unqualified period
C. A short clean-up period (<20 minutes)
D. Only during manual operation
Answer: C
Questions 5. Occasional macro particle counts (≥5 µm) in Grade A may be due to:
A. High humidity
B. Electronic noise or stray light
C. Poor operator gowning only
D. Media contamination
Answer: B
Questions 6. Consecutive low-level macro particle counts in Grade A may indicate:
A. False results
B. Airflow improvement
C. Possible contamination events
D. Reduced pressure differentials
Answer: C
Questions 7. Regular macro particle counts in Grade A may signal early:
A. Gowning errors only
B. Changes in media
C. Filtration system failure
D. Temperature failure
Answer: C
Questions 8. Particle monitoring in Grade A should cover:
A. Only filling
B. Only media preparation
C. Full duration of critical processing
D. Only after batch completion
Answer: C
Questions 9. Grade A areas should be monitored continuously for particles ≥0.5 µm and:
A. ≥1 µm
B. ≥2 µm
C. ≥5 µm
D. ≥0.1 µm
Answer: C
Questions 10. Minimum sample flow rate for Grade A monitoring is:
A. 5 L/min
B. 10 L/min
C. 28 L/min
D. 100 L/min
Answer: C
Questions 11. Continuous monitoring should capture:
A. Holidays
B. Interventions and transient events
C. Only microbial results
D. Only operator activities
Answer: B
Questions 12. Systems should correlate each sample result with:
A. Climate data
B. Alert and action levels
C. Operator experience levels
D. Raw material specifications
Answer: B
Questions 13. When alert levels are exceeded, the system should:
A. Shut down automatically
B. Trigger alarms
C. Ignore the results
D. Reduce sampling
Answer: B
Questions 14. Procedures must define actions to be taken after:
A. Training completion
B. Alarm conditions
C. Media purchase
D. Batch release
Answer: B
Questions 15. In response to alarms, additional ____ may be considered:
A. Temperature checks
B. Microbial monitoring
C. Pressure mapping
D. Noise assessments
Answer: B
Questions 16. Grade B areas should use:
A. Continuous monitoring identical to Grade A always
B. No monitoring
C. A similar system with decreased sample frequency
D. Only visual inspection
Answer: C
Questions 17. Grade B monitoring should capture:
A. Door opening frequency
B. Any increase in contamination levels
C. Only viable particles
D. Only HEPA filter noise
Answer: B
Questions 18. If Grade B alert levels are exceeded:
A. Data should be archived only
B. No action is needed
C. Alarms should be triggered
D. Monitoring should stop
Answer: C
Questions 19. Selection of monitoring systems should consider risks from:
A. Packaging materials
B. Office supplies
C. Live organisms, powdery products, radiopharmaceuticals
D. Operator handwriting
Answer: C
Questions 20. Particle counters may be damaged by contaminants such as:
A. Water vapour
B. Live organisms, powdery products, radiation hazards
C. Compressed air
D. Temperature changes
Answer: B
Questions 21. When contaminants pose hazards, monitoring strategies must ensure:
A. Faster batch release
B. Environmental classification pre- and post-exposure
C. Elimination of monitoring
D. Only manual sampling
Answer: B
Questions 22. In hazardous processes, viable particle monitoring should:
A. Be reduced
B. Remain unchanged
C. Be increased
D. Be eliminated
Answer: C
Questions 23. Monitoring must also be performed during:
A. Unrelated operations
B. Simulated operations
C. Cleaning only
D. Staff meetings
Answer: B
Questions 24. Simulated operations should be performed:
A. Randomly if operator wishes
B. At appropriate intervals
C. Only during audits
D. Only in Grade C
Answer: B
Questions 25. The approach to hazardous monitoring must be defined in the:
A. SOP for gowning
B. HVAC manual
C. CCS (Contamination Control Strategy)
D. Operator logbook
Answer: C
Questions 26. Sample size for automated systems usually depends on:
A. Batch size
B. Sampling rate of the system
C. Operator level
D. Filter age
Answer: B
Questions 27. Monitoring sample volume does NOT need to match:
A. Formal classification volumes
B. Operator expectations
C. Media fill volumes
D. Automated data logs
Answer: A
Questions 28. Monitoring sample volumes should be:
A. Fixed for all systems
B. Arbitrary
C. Justified
D. Chosen by operators
Answer: C
Questions 29. Continuous monitoring in Grade A should detect:
A. Routine paperwork
B. Any system deterioration
C. Operator preferences
D. Only airborne bacteria
Answer: B
Questions 30. Macro particle counts in Grade A require investigation when:
A. They are consecutive or regular
B. They occur once a year
C. They occur during cleaning only
D. They are below 0.5 µm
Answer: A
Reference – EU Guidelines for GMP- Annex-1