Premises – Cleanrooms and Sterile Manufacturing EUGMP- Annex-1
Questions 1. The manufacture of sterile products should be carried out in:
A. Any closed room
B. Appropriate cleanrooms
C. Open production areas
D. Grade D rooms only
Answer: B
Questions 2. Entry to cleanrooms should be through:
A. Storage rooms
B. Offices
C. Change rooms acting as airlocks
D. Air-showers only
Answer: C
Questions 3. Air supplied to cleanrooms must pass through:
A. Domestic air filters
B. Activated carbon filters
C. Filters of an appropriate efficiency
D. No filters
Answer: C
Questions 4. Controls and monitoring in cleanrooms should be:
A. Optional
B. Minimally justified
C. Scientifically justified
D. Based on operator judgement
Answer: C
Questions 5. Component preparation and filling should be separated to prevent:
A. Operator fatigue
B. Equipment congestion
C. Mix-up and contamination
D. Increased costs
Answer: C
Questions 6. RABS and isolators help minimize contamination from:
A. Equipment failure
B. Direct human interventions
C. Cleaning agents
D. HVAC systems
Answer: B
Questions 7. Alternatives to RABS or isolators should be:
A. Ignored
B. Allowed without review
C. Justified
D. Rejected automatically
Answer: C
Barrier Technologies in Pharma
Cleanroom Grades
Questions 8. Grade A represents:
A. The lowest cleanliness grade
B. The background environment for storage
C. The critical zone for high-risk operations
D. The standard warehouse grade
Answer: C
Questions 9. Grade A conditions are normally provided by:
A. Horizontal laminar benches only
B. Localized airflow protection with unidirectional flow
C. General room ventilation
D. Manual fans
Answer: B
Questions 10. Direct operator intervention in Grade A should be:
A. Encouraged
B. Minimized
C. Performed frequently
D. Required
Answer: B
Questions 11. Grade B is:
A. A warehouse area
B. Background cleanroom for Grade A
C. Used only for packaging
D. Equivalent to unclassified areas
Answer: B
Questions 12. Air pressure differences in Grade B should be:
A. Not monitored
B. Monitored only weekly
C. Continuously monitored
D. Monitored only during shutdown
Answer: C
Questions 13. Grades C and D are used for:
A. High-risk aseptic filling
B. Less critical operations
C. Outdoor processing
D. Administrative activities
Answer: B
Cleanroom Design Features
Questions 14. Surfaces in cleanrooms must be:
A. Rugged and textured
B. Smooth and impervious
C. Porous and soft
D. Carpeted
Answer: B
Questions 15. Projections such as shelves should be:
A. Maximized
B. Made of wood
C. Minimized
D. Encouraged
Answer: C
Questions 16. Sliding doors are:
A. Preferred
B. Not permitted at all
C. Undesirable due to cleaning difficulty
D. Mandatory
Answer: C
Questions 17. Materials used in cleanrooms should:
A. Minimize particle generation
B. Be chosen for aesthetics
C. Be porous
D. Be disposable
Answer: A
Questions 18. Ceilings must be:
A. Open for easy access
B. Sealed to prevent contamination from above
C. Painted black
D. Unfinished
Answer: B
Questions 19. Sinks and drains are prohibited in:
A. Grade C and D
B. Grade B only
C. Grade A and B
D. All clean areas
Answer: C
Questions 20. Floor drains in lower-grade cleanrooms must have:
A. No traps
B. Water seals
C. Large openings
D. No cleaning requirements
Answer: B
Transfer of Materials and Equipment
Questions 21. Material transfer is a major source of:
A. Equipment failure
B. Temperature fluctuations
C. Contamination
D. Noise
Answer: C
Questions 22. Transfer to Grade A/B should be:
A. Bidirectional
B. Unidirectional
C. Random
D. Manual only
Answer: B
Questions 23. Ideally, items entering Grade A/B areas should be:
A. Washed only
B. Unsterilised
C. Sterilised and passed through double-ended sterilizers
D. Carried by operators
Answer: C
Questions 24. When sterilization is not possible, transfer must use:
A. A validated alternative method
B. No control measures
C. Random procedures
D. Operator discretion
Answer: A
Questions 25. Removal of items from Grade A/B should be:
A. Using same path as entry
B. Prohibited
C. Via separate unidirectional process
D. Through windows
Answer: C
Airlocks and Pass-Through Hatches
Questions 26. Airlocks provide:
A. Additional storage
B. Recreation space
C. Physical separation to minimize contamination
D. Temperature control
Answer: C
Questions 27. Personnel airlocks should include:
A. Hand washing in all stages
B. Hand washing only in first stage
C. No hand washing
D. Showers in all stages
Answer: B
Questions 28. Movement of unapproved items into Grade A/B must be:
A. Ignored
B. Pre-approved as exception
C. Encouraged
D. Fully prohibited
Answer: B
Questions 29. Pass-through hatches must:
A. Be unventilated
B. Protect higher-grade environments
C. Remain open
D. Contain sinks
Answer: B
Questions 30. Entry and exit doors of airlocks should:
A. Be opened together
B. Never be closed
C. Not open simultaneously
D. Only be monitored visually
Answer: C
Questions 31. Airlocks to Grade A/B must use:
A. Visual signs only
B. No warning systems
C. Interlocking systems
D. Key-operated doors
Answer: C
Questions 32. Airlocks to Grades C/D require at minimum:
A. Interlocks
B. Alarmed cages
C. Visual and/or audible warnings
D. Double isolation barriers
Answer: C
Air Supply and Pressure
Questions 33. Cleanrooms must maintain:
A. Negative pressure in all cases
B. Positive pressure relative to lower grades
C. Equal pressures
D. Zero airflow
Answer: B
Questions 34. Adjacent cleanrooms should have a pressure difference of:
A. 1 Pascal
B. 3 Pascals
C. 10 Pascals (guidance)
D. 50 Pascals minimum
Answer: C
Questions 35. When hazardous materials require containment, pressure:
A. Must always remain positive
B. May be modified
C. Should be ignored
D. Is irrelevant
Answer: B
Questions 36. Airflow patterns must be visualized to ensure:
A. Noise levels remain low
B. No ingress from lower grades
C. Comfort for operators
D. Savings on HVAC costs
Answer: B
Questions 37. Airflow visualization studies must be done:
A. Only at rest
B. Only during shutdown
C. At rest and in operation
D. Only annually
Answer: C
Questions 38. Airflow visualization should be:
A. Immediately erased
B. Retained on video
C. Not recorded
D. Recorded only as sketches
Answer: B
Air Pressure Indicators and Alarms
Questions 39. Air pressure indicators should be fitted:
A. Only in Grade A
B. Between cleanrooms
C. Outside the building
D. Only in warehouses
Answer: B
Questions 40. Critical air pressure differences should be:
A. Measured monthly
B. Randomly checked
C. Continuously monitored
D. Ignored
Answer: C
Questions 41. Warning systems must:
A. Be optional
B. Instantly indicate failures
C. Be disabled during operations
D. Be overridden when inconvenient
Answer: B
Questions 42. Alarm delays must be:
A. Avoided
B. Set without justification
C. Assessed and justified
D. Based on convenience
Answer: C
Facility Observation and Design
Questions 43. Facilities should allow observation of Grade A/B areas via:
A. Binoculars
B. Windows or remote cameras
C. Mirrors
D. Open doors
Answer: B
Questions 44. Change rooms should act as:
A. Storage rooms
B. Offices
C. Airlocks
D. Garment repair centers
Answer: C
Questions 45. Cleanroom materials must tolerate:
A. No cleaning
B. Repeated application of disinfectants
C. Only water cleaning
D. UV light only
Answer: B
Questions 46. To prevent contamination, doors should avoid:
A. Being colorful
B. Having recesses
C. Automatic closing
D. Metal frames
Answer: B
Questions 47. Backflow in drains is prevented by:
A. Larger diameter pipes
B. Water seals or traps
C. Electrical sensors
D. Extra ventilation
Answer: B
Questions 48. Items moving into higher-grade areas must undergo:
A. Standard shipping procedures
B. Cleaning and disinfection as per CCS
C. No documentation
D. Casually applied cleaning
Answer: B
Questions 49. Interlocked doors help maintain:
A. HVAC cost savings
B. Area segregation
C. Staff convenience
D. Rapid movement
Answer: B
Questions 50. Pressure sources for air flowing into critical zones must come from:
A. Lower-grade areas
B. Unclassified rooms
C. Same or higher grade
D. The outdoors
Answer: C
Questions 51. The final stage of an airlock should match:
A. The cafeteria cleanliness
B. The highest grade in the facility
C. The grade of the cleanroom it leads to
D. Warehouse conditions
Answer: C
Questions 52. Personnel and material movement airlocks should be:
A. Interchangeable
B. Preferably separated
C. Used randomly
D. Always combined
Answer: B
Questions 53. Items moving through Grade B toward Grade A should be:
A. Unpackaged
B. Exposed
C. Protected
D. Stored in cardboard
Answer: C
Questions 54. Airflow visualization helps design:
A. Environmental monitoring programme
B. Staff uniforms
C. Equipment color schemes
D. Office layout
Answer: A
Questions 55. Where risk of contamination is high, changing rooms:
A. Should be a single room
B. Should be separate for entry and exit
C. Should be unventilated
D. Should be optional
Answer: B
Questions 56. Material airlocks can transfer only items:
A. Approved on a validated list
B. Chosen by operators
C. New and untested
D. From any supplier
Answer: A
Questions 57. Airlocks should be flushed with:
A. Unfiltered air
B. Filtered air
C. Oxygen
D. Nitrogen
Answer: B
Questions 58. Cleanrooms handling pathogenic materials may require:
A. Less monitoring
B. Modified pressure regimes
C. No airflow
D. Operator-only controls
Answer: B
Questions 59. Any override of warning signals must require:
A. No record
B. Prior assessment
C. Operator preference
D. Automatic approval
Answer: B
Questions 60. Facility design aiming to prevent unnecessary entry into Grade A/B promotes:
A. Remote observation
B. High staff presence
C. Frequent door opening
D. Manual supervision only
Answer: A