Cleanroom and clean air equipment qualification in Pharma EUGMP- Annex-1
Questions 1. Cleanrooms and clean air equipment used for sterile products must be qualified according to:
A. Market requirements
B. Required characteristics of the environment
C. Operator preference
D. Equipment size
Answer: B
Questions 2. The operational environmental cleanliness level is necessary to minimize:
A. Equipment downtime
B. Personnel fatigue
C. Risk of contamination of product or materials
D. Cost of production
Answer: C
Questions 3. Cleanrooms must maintain cleanliness levels in which two states?
A. Day and night
B. Warm and cold
C. “At rest” and “operational”
D. Static and dynamic
Answer: C
Questions 4. Cleanroom qualification should be done according to:
A. Annex 15 requirements
B. Annex 11 requirements
C. ISO 9001
D. FDA CFR Part 820
Answer: A
Questions 5. Cleanroom qualification must be clearly differentiated from:
A. Vendor audits
B. Operational environmental monitoring
C. Microbiological testing
D. Material handling testing
Answer: B
Questions 6. Clean air equipment includes:
A. RABS, isolators, UDAFs
B. Dishwashers
C. Steam generators
D. Dehumidifiers
Answer: A
Questions 7. The goal of cleanroom qualification is to assess:
A. Cost effectiveness
B. Aesthetic appearance
C. Compliance with intended use
D. Operator comfort
Answer: C
Questions 8. Which test checks the integrity of HEPA/ULPA filters?
A. Recovery test
B. Filter system leakage test
C. Humidity test
D. Temperature measurement
Answer: B
Questions 9. Airflow tests measure:
A. Only velocity
B. Only temperature
C. Both volume and velocity
D. Filter resistance
Answer: C
Questions 10. Air pressure difference testing is performed to ensure:
A. Proper lighting
B. Proper differential air pressure between rooms
C. Product yield improvement
D. Lower energy consumption
Answer: B
Questions 11. Airflow direction tests include:
A. Sound measurement
B. Visualization
C. Chemical detection
D. Air filtration checks
Answer: B
Questions 12. Microbial testing during qualification includes:
A. Only air testing
B. Only surface testing
C. Airborne and surface contamination
D. Only personnel testing
Answer: C
Questions 13. Temperature test ensures:
A. Equipment efficiency
B. Room temperature is within limits
C. Personnel comfort
D. Filter resistance
Answer: B
Questions 14. Humidity tests measure:
A. Absolute humidity only
B. Relative humidity
C. Dew point
D. Condensation potential
Answer: B
Questions 15. Recovery test measures how quickly the cleanroom:
A. Adjusts pressure
B. Recovers temperature
C. Returns to required cleanliness after contamination
D. Reaches operational capacity
Answer: C
Questions 16. Containment leak tests are required to verify:
A. Noise levels
B. Containment integrity
C. Lighting
D. Electrical safety
Answer: B
Questions 17. Qualification guidance may be referenced from:
A. ISO 22000
B. ISO 14644 series
C. FDA 21 CFR 211
D. ICH Q11
Answer: B
Questions 18. Cleanroom classification assesses:
A. Air humidity
B. Air cleanliness level by particle concentration
C. Water purity
D. Vibration levels
Answer: B
Questions 19. Classification should avoid impacting:
A. Equipment cost
B. Process or product quality
C. Energy consumption
D. Operator movement
Answer: B
Questions 20. Initial classification is performed during:
A. Rest only
B. Routine production
C. Simulated operations
D. Personnel qualification
Answer: C
Questions 21. Reclassification may be performed during:
A. Weekends
B. Simulated operations or APS
C. Operator training
D. Cleaning validation
Answer: B
Questions 22. Which particle sizes must be measured for classification?
A. ≥0.1 μm and ≥1.0 μm
B. ≥0.5 μm and ≥5 μm
C. ≥10 μm only
D. ≥50 μm only
Answer: B
Questions 23. Classification must be done:
A. Only in operation
B. Only at rest
C. At rest and in simulated operations
D. Only during maintenance
Answer: C
Questions 24. 5 μm particle classification may be included when:
A. Operator requests
B. Indicated by CCS or historical trends
C. Auditor insists
D. Equipment is new
Answer: B
Questions 25. For Grade D, in operation limits:
A. Are predetermined in guidelines
B. Do not exist; manufacturer must define
C. Are stricter than Grade A
D. Are the same as Grade B
Answer: B
Questions 26. Minimum sampling locations for classification are found in:
A. ISO 9001
B. ISO 17025
C. ISO 14644 Part 1
D. Annex 1 only
Answer: C
Questions 27. Additional sample locations must be considered in:
A. Grade C only
B. Grade D only
C. Grade A and B areas
D. Warehouse
Answer: C
Questions 28. Critical locations include:
A. Restrooms
B. Office areas
C. Point of fill and feeder bowls
D. Locker rooms
Answer: C
Questions 29. Critical processing locations are determined by:
A. Auditor preference
B. Random selection
C. Documented risk assessment
D. Supplier agreement
Answer: C
Questions 30. “At rest” means:
A. Equipment operating without personnel
B. HVAC off
C. Equipment installed but not operating; no personnel
D. No equipment installed
Answer: C
Questions 31. “In operation” means:
A. Cleanroom empty
B. Only HVAC operating
C. Equipment running with maximum personnel performing routine work
D. Maintenance activities only
Answer: C
Questions 32. “Clean up” period after operations should be:
A. Less than 5 minutes
B. Less than 20 minutes
C. Less than 1 hour
D. Undefined
Answer: B
Questions 33. Clean up period must be:
A. Estimated by operators
B. Determined during qualification and documented
C. Chosen by quality manager
D. Changed weekly
Answer: B
Questions 34. Air speed in UDAFs must be:
A. Random
B. 0.10–0.20 m/s
C. 0.36–0.54 m/s (guidance)
D. Higher than 1.0 m/s
Answer: C
Questions 35. Air speed justification must be included in:
A. Cleaning SOP
B. Validation protocol
C. Qualification protocol
D. Purchase order
Answer: C
Questions 36. Airflow must protect:
A. Operators only
B. Floors
C. Exposed product and components
D. Doors
Answer: C
Questions 37. Airflow visualization must correlate with:
A. Noise levels
B. Temperature mapping
C. Air speed measurements
D. Lighting intensity
Answer: C
Questions 38. Microbial sampling locations are based on:
A. Auditor preference
B. Cost limitations
C. Documented risk assessment
D. Vendor agreement
Answer: C
Questions 39. Qualification must include microbial testing in:
A. Only at rest
B. Only in operation
C. Both at rest and in operation
D. Only during shutdown
Answer: C
Questions 40. Settle plates must be exposed for:
A. 1 hour maximum
B. 8 hours minimum
C. Duration of operations, changed every max 4 hours
D. Random intervals
Answer: C
Questions 41. Exposure time for settle plates must avoid:
A. Overgrowth
B. Media desiccation
C. Condensation
D. Colour change
Answer: B
Questions 42. If alternative microbial methods are used, limits must be:
A. Ignored
B. More lenient
C. Scientifically justified and correlated to CFU
D. Removed completely
Answer: C
Questions 43. Sampling methods should not:
A. Involve operators
B. Require cleaning
C. Pose contamination risk to manufacturing
D. Include temperature measurement
Answer: C
Questions 44. Requalification should follow:
A. Operator discretion
B. No specific requirements
C. Defined procedures
D. Vendor instructions
Answer: C
Questions 45. Requalification must include:
A. Only microbial tests
B. Only air velocity tests
C. Classification, filter integrity, airflow, pressure difference
D. Personnel counts
Answer: C
Questions 46. Filter integrity tests must be repeated during:
A. Daily cleaning
B. Requalification
C. Every batch
D. Equipment shutdown
Answer: B
Questions 47. For Grade B, C, D, air velocity tests are required based on:
A. Cost analysis
B. Supervisor decision
C. Risk assessment in CCS
D. Operator preference
Answer: C
Questions 48. Recovery testing replaces air velocity testing for areas with:
A. No HVAC
B. Non-unidirectional airflow
C. High temperature
D. Isolators
Answer: B
Questions 49. Max interval for requalification of Grade A and B:
A. 1 month
B. 6 months
C. 12 months
D. 24 months
Answer: B
Questions 50. Max interval for requalification of Grade C and D:
A. 3 months
B. 6 months
C. 12 months
D. 24 months
Answer: C
Questions 51. Requalification must be repeated after:
A. Any equipment cleaning
B. Remedial action for out-of-compliance condition
C. Every product batch
D. Every delivery
Answer: B
Questions 52. Change significance must be determined through:
A. Risk classification
B. Change management process
C. Operator feedback
D. Annual review
Answer: B
Questions 53. Requalification may be needed after:
A. New employee hiring
B. Change in cleaning personnel
C. Interruption of air movement
D. Replacing chairs
Answer: C
Questions 54. A change in HVAC design:
A. Never requires requalification
B. Always requires requalification
C. May require requalification depending on risk
D. Is handled by maintenance only
Answer: C
Questions 55. Cleanroom classification measures particle concentration against:
A. Lighting output
B. Vibration levels
C. A specification
D. Power consumption
Answer: C
Questions 56. Classification during APS helps evaluate:
A. Cleaning effectiveness
B. Realistic operational conditions
C. Operator training
D. Material flow
Answer: B
Questions 57. Additional sample points are required in Grade A/B areas because:
A. They are the least critical
B. Procedures are easier
C. They include critical processing operations
D. Sampling is cheaper
Answer: C
Questions 58. Airflow must be homogeneous to ensure:
A. Operator comfort
B. Correct room temperature
C. Proper protection of exposed product
D. Uniform humidity
Answer: C
Questions 59. Recovery testing evaluates how fast the room:
A. Recovers temperature
B. Recovers pressure
C. Returns to particle limits after contamination
D. Clears personnel
Answer: C
Questions 60. Qualification and requalification ensure that cleanrooms remain:
A. Cost-efficient
B. Aesthetic
C. Fit for their intended use
D. Comfortable for staff
Answer: C