Environmental and personnel monitoring – viable particle EUGMP- Annex-1
Questions 1. Microbial monitoring in aseptic operations should be:
A. Rare
B. Performed only weekly
C. Frequent
D. Optional
Answer: C
Questions 2. A combination of methods for microbial monitoring may include:
A. Chemical analysis
B. Settle plates, air sampling, glove, gown, surface sampling
C. Weight measurements
D. Only visual inspection
Answer: B
Questions 3. The sampling method used must be justified in the:
A. Audit program
B. CCS (Contamination Control Strategy)
C. Validation master plan
D. Engineering manual
Answer: B
Questions 4. Sampling methods must not negatively impact:
A. Equipment cleaning
B. Grade A and B airflow patterns
C. HVAC pressure maps
D. Media preparation
Answer: B
Questions 5. Cleanroom and equipment surfaces should be monitored:
A. Before operation only
B. At the end of an operation
C. During lunch breaks
D. Weekly
Answer: B
Questions 6. Viable particle monitoring should also occur when manufacturing is:
A. At peak speed
B. Not occurring
C. Automated
D. Completed successfully
Answer: B
Questions 7. Monitoring after shutdown periods is used to detect:
A. Equipment noise
B. Airflow direction
C. Potential contamination incidents
D. Operator performance
Answer: C
Questions 8. Additional sampling locations may be used for:
A. Decoration
B. Corrective action verification
C. Reducing monitoring frequency
D. Limiting airflow
Answer: B
Questions 9. Continuous viable air monitoring in Grade A must cover:
A. Half of the process
B. Only filling
C. Full duration of critical processing
D. Only environmental sampling
Answer: C
Questions 10. Grade B cleanrooms should consider continuous monitoring based on:
A. Cost
B. Operator preference
C. Risk to aseptic processing
D. Batch size
Answer: C
Questions 11. Monitoring should capture:
A. Noise levels
B. Operator moods
C. Interventions and system deterioration
D. Only HVAC alerts
Answer: C
Questions 12. Monitoring should avoid creating:
A. Additional airflow
B. Risk due to monitoring operations
C. Positive pressure
D. Temperature changes
Answer: B
Questions 13. A risk assessment should determine personnel monitoring:
A. Salaries
B. Locations, type, and frequency
C. Vacation schedules
D. Labelling procedures
Answer: B
Questions 14. Personnel monitoring should be performed:
A. Daily regardless of activity
B. At periodic intervals during the process
C. Only after batch completion
D. Every hour
Answer: B
Questions 15. Personnel sampling must not:
A. Follow interventions
B. Occur in cleanrooms
C. Compromise the process
D. Require gloves
Answer: C
Questions 16. After critical interventions, personnel should have at least:
A. Shoes cleaned
B. Hair covered
C. Gloves monitored
D. No monitoring
Answer: C
Questions 17. Following glove monitoring after interventions, gloves should be:
A. Disinfected only
B. Replaced
C. Dried
D. Inspected visually
Answer: B
Questions 18. If gown monitoring is required after interventions, the gown must be:
A. Repaired
B. Replaced
C. Washed
D. Inspected visually
Answer: B
Questions 19. Microbial monitoring of personnel should occur in:
A. Grade A and B areas
B. Grade D only
C. Rest areas
D. Warehouse
Answer: A
Questions 20. Manual operations increase risk, requiring:
A. Less monitoring
B. No glove checks
C. Enhanced emphasis on gown monitoring
D. Fewer operators
Answer: C
Questions 21. If monitoring is performed by manufacturing personnel, it should have:
A. No oversight
B. Oversight by quality unit
C. Oversight by engineering
D. External consulting only
Answer: B
Questions 22. Adoption of rapid monitoring methods should:
A. Reduce validation requirements
B. Decrease monitoring frequency
C. Expedite contamination detection
D. Replace all classical methods without validation
Answer: C
Questions 23. Rapid microbial methods may be adopted after:
A. Cost analysis
B. Validation proves equivalency or superiority
C. Supplier recommendation
D. IT approval
Answer: B
Questions 24. Sampling methods and equipment should be:
A. Operated based on intuition
B. Fully understood
C. Used without instruction
D. Optional
Answer: B
Questions 25. Procedures must exist for:
A. Correct sampling operation and interpretation
B. Hiring new staff
C. Accounting audits
D. Warehouse management
Answer: A
Questions 26. Recovery efficiency data should be:
A. Discarded
B. Estimated
C. Available for chosen sampling methods
D. Irrelevant
Answer: C
Questions 27. Settle plates in Grade A and B areas should be exposed:
A. For 1 hour maximum
B. For entire operation (max 4 hours)
C. Only during night shift
D. Only after completion
Answer: B
Questions 28. Settle plate exposure time should be based on:
A. Operator preference
B. Media color
C. Validation including recovery studies
D. Equipment age
Answer: C
Questions 29. Settle plate exposure must not negatively affect:
A. Operator training
B. Suitability of media
C. HVAC noise
D. Packaging
Answer: B
Questions 30. Exposure time in Grade C and D areas should be based on:
A. QRM (Quality Risk Management)
B. Customer request
C. Cost management
D. Operator choice
Answer: A
Questions 31. Individual settle plates may be exposed:
A. Exactly 4 hours
B. Less than 4 hours
C. Only more than 4 hours
D. Only during filling
Answer: B
Questions 32. Contact plate limits apply to surfaces in:
A. Grade D only
B. Grade C only
C. Grade A and B areas
D. Unclassified areas
Answer: C
Questions 33. Routine gown monitoring is normally not required for:
A. Grade A
B. Grade B
C. Grade C and D
D. Any grade
Answer: C
Questions 34. In Grade A, any microbial growth should lead to:
A. Disposal of the gown
B. Operator retraining only
C. An investigation
D. Ignoring the result
Answer: C
Questions 35. Monitoring methods listed are:
A. Mandatory and exclusive
B. Examples, alternatives allowed
C. Not acceptable
D. Fixed and unchangeable
Answer: B
Questions 36. If monitoring methods produce results not in CFU, limits must be:
A. Removed
B. Scientifically justified and correlated to CFU if possible
C. Invented arbitrarily
D. Ignored
Answer: B
Questions 37. Microorganisms detected in Grade A and B areas should be identified to:
A. Family level
B. Genus level
C. Species level
D. Strain level always
Answer: C
Questions 38. Identification of microorganisms in Grade C and D should be considered when:
A. Activity is minimal
B. Alert or action limits are exceeded
C. Operators request it
D. HVAC is off
Answer: B
Questions 39. Identification in Grade C and D areas is also needed when:
A. Moulds or spore-formers appear
B. All results are zero
C. Plates dry out
D. Operators change shifts
Answer: A
Questions 40. Identification helps evaluate:
A. Product labeling
B. Product price
C. Impact on product quality and state of control
D. Media expiry
Answer: C
Questions 41. Personnel monitoring after critical interventions should include monitoring of:
A. Shoes
B. Gloves at minimum
C. Hair
D. Boots
Answer: B
Questions 42. Personnel exiting Grade B cleanrooms must have:
A. Hair monitored
B. Gloves and gown monitored
C. Shoes disinfected
D. No monitoring
Answer: B
Questions 43. Monitoring of gloves after interventions requires glove:
A. Drying
B. Reuse
C. Replacement
D. Washing only
Answer: C
Questions 44. Monitoring must capture transient events because:
A. They may indicate momentary contamination risks
B. They are part of routine audits
C. They help document temperature
D. They support inventory tracking
Answer: A
Questions 45. Monitoring operations must be performed so that they:
A. Increase risk
B. Do not compromise aseptic processing
C. Slow down the process
D. Replace interventions
Answer: B
Questions 46. Enhanced gown monitoring is especially important for:
A. Automated lines
B. Manual operations
C. Packaging areas
D. Warehouses
Answer: B
Questions 47. Quality unit oversight ensures:
A. Faster monitoring
B. Compliance with procedures
C. Higher production output
D. Less documentation
Answer: B
Questions 48. Rapid methods must be validated to show:
A. Lower cost
B. Aesthetic benefits
C. Equivalency or superiority to classical methods
D. Simpler installation
Answer: C
Questions 49. Microorganism identification in C and D areas should be done at sufficient frequency to:
A. Increase paperwork
B. Track typical flora
C. Reduce sampling
D. Reduce media costs
Answer: B
Questions 50. Detection of microorganisms that indicate loss of control includes:
A. Viruses
B. Moulds and spore-formers
C. Animal cells
D. Plant cells
Answer: B
Reference – EU Guidelines for GMP- Annex-1