Questions & Answers Utilities, Water Systems, Steam, Gases, and Heating/Cooling Systems EUGMP- Annex-1
Question 1. The level of controls applied to utility systems should be based on:
A. Historical data
B. Auditor preference
C. Risk to product quality
D. Cost of maintenance
ANSWER – C
Question 2. Utility system impact must be assessed and documented as part of the:
A. Preventive Maintenance Plan
B. CCS (Contamination Control Strategy)
C. Training Matrix
D. Recall Process
ANSWER – B
Question 3. Which of the following is considered a high-risk utility?
A. Lighting system
B. HVAC condensate
C. Utilities that directly contact the product
D. Office compressed air
ANSWER – C
Question 4. A utility that contacts materials that ultimately become part of the product is considered:
A. Low risk
B. Moderate risk
C. High risk
D. No risk
ANSWER – C
Question 5. Utilities must be designed, qualified, maintained, and monitored to:
A. Improve building energy efficiency
B. Ensure the system functions as expected
C. Reduce employee workload
D. Meet financial targets
ANSWER – B
Question 6. Critical parameters of high-risk utilities should be subject to:
A. Annual review only
B. Regular trend analysis
C. Only manual checks
D. No monitoring
ANSWER – B
Question 7. Utility installation records must include:
A. Equipment prices
B. Staff shift schedules
C. Current drawings and system specifications
D. Manufacturing batch records
ANSWER – C
Question 8. Pipeline installation records should include:
A. Employee qualifications
B. Pipeline flow direction and slopes
C. Vendor audit reports
D. Cleaning SOPs
ANSWER – B
Question 9. Pipes and ducts should NOT be present in cleanrooms unless:
A. Required for production
B. Avoidable
C. Unavoidable
D. Cheap to install
ANSWER – C
Question 10. If pipes must be present in cleanrooms, they should be:
A. Buried in walls
B. Installed to avoid recesses and allow easy cleaning
C. Left exposed without cleaning access
D. Painted for easier identification
ANSWER – B
Question 11. Water systems must be designed and maintained to prevent:
A. Excessive temperature
B. Noise
C. Microbiological contamination
D. Water hardness
ANSWER – C
Question 12. Measures to reduce microbial contamination in water systems include:
A. Using high pressure
B. Sloping pipes for drainage
C. Adding dyes
D. Storing water at room temperature
ANSWER – B
Question 13. Water produced should comply with:
A. Internal SOPs only
B. Current monograph of the relevant Pharmacopeia
C. VIP inspection reports
D. Management approval
ANSWER – B
Question 14. Water systems must consider seasonal variation during:
A. Calibration
B. Qualification and validation
C. Construction only
D. Risk assessment only
ANSWER – B
Question 15. Turbulent flow in water distribution systems helps prevent:
A. System vibration
B. Biofilm formation
C. Rust
D. Evaporation
ANSWER – B
Question 16. Required flow rates for water systems must be:
A. Estimated
B. Recorded during validation only
C. Established during qualification and routinely monitored
D. Not monitored
ANSWER – C
Question 17. WFI should be stored and distributed to minimize:
A. Temperature fluctuations only
B. Microbial growth
C. Operator handling
D. Particulate shedding
ANSWER – B
Question 18. WFI distribution temperature is typically maintained:
A. Below 20°C
B. Above 70°C
C. At 35°C
D. Room temperature
ANSWER – B
Question 19. WFI may be produced by distillation or:
A. UV irradiation alone
B. Reverse osmosis + appropriate techniques
C. Carbon filtration alone
D. Chlorination
ANSWER – B
Question 20. Hydrophobic vent filters on WFI tanks must be tested:
A. Every five years
B. Only before installation
C. Before installation and after use
D. Never
ANSWER – C
Question 21. Controls must prevent what from forming on vent filters?
A. Dust buildup
B. Condensation
C. Oil residue
D. Ice crystals
ANSWER – B
Question 22. Water system sterilisation or disinfection must follow:
A. Operator preference
B. A predetermined schedule
C. Annual review
D. No documented plan
ANSWER – B
Question 23. Chemical disinfection must be followed by:
A. A validated rinsing procedure
B. Visual inspection only
C. Microbial testing only
D. Immediate system restart
ANSWER – A
Question 24. Microbial/endotoxin test results must be approved before:
A. Cleaning equipment
B. Water system is returned to use
C. The next audit
D. Any maintenance is done
ANSWER – B
Question 25. Routine chemical and microbial monitoring of water systems is:
A. Optional
B. Required only annually
C. Required regularly
D. Only for new systems
ANSWER – C
Question 26. Sampling programmes must include:
A. A single outlet
B. All outlets and points of use at specified intervals
C. Only critical points
D. Only routine sampling of tanks
ANSWER – B
Question 27. Sample plans must ensure that at least one representative sample is taken:
A. Per month
B. Every hour
C. Every day that water is used in manufacturing
D. Only during qualification
ANSWER – C
Question 28. Alert level excursions require:
A. No action
B. Documentation and review
C. Automatic shutdown
D. Operator reprimand
ANSWER – B
Question 29. Action limit excursions require investigation of:
A. Market complaints
B. Root cause and impact on product quality
C. Employee attendance
D. Utility cost
ANSWER – B
Question 30. WFI systems should include continuous monitoring such as:
A. UV absorbance only
B. TOC and conductivity
C. Pressure only
D. Color monitoring
ANSWER – B
Question 31. Sensor locations for WFI continuous monitoring must be based on:
A. Equipment availability
B. Operator preference
C. Risk
D. Cost
ANSWER – C
Question 32. Feed water to a clean steam generator must be:
A. Softened only
B. Appropriately purified
C. At room temperature
D. Chlorinated
ANSWER – B
Question 33. Clean steam must meet defined:
A. Noise levels
B. Color criteria
C. Chemical and endotoxin limits
D. Odor criteria
ANSWER – C
Question 34. Pure steam used for sterilisation must have condensate that meets the monograph for:
A. Drinking water
B. Sterile water for irrigation
C. WFI
D. Process water
ANSWER – C
Question 35. Microbial testing of pure steam condensate is:
A. Mandatory
B. Not mandatory
C. Optional
D. Prohibited
ANSWER – B
Question 36. Quality of pure steam should be assessed periodically against:
A. HVAC setpoints
B. Vendor recommendations
C. Validated parameters
D. Marketing requirements
ANSWER – C
Question 37. Validated parameters for steam include:
A. pH and color
B. Non-condensable gases, dryness, superheat
C. Conductivity only
D. TOC only
ANSWER – B
Question 38. Gases contacting product surfaces must meet appropriate:
A. Color and odor
B. Chemical, particulate, and microbial quality
C. Oxygen content
D. Pressure levels only
ANSWER – B
Question 39. Gases used in aseptic processes must be filtered with maximum pore size:
A. 0.45 µm
B. 5.0 µm
C. 1.0 µm
D. 0.22 µm
ANSWER – D
Question 40. Filters used on a batch basis must be:
A. Stored outdoors
B. Replaced after each use
C. Integrity tested and reviewed during batch release
D. Not labeled
ANSWER – C
Question 41. Any pipework after the final sterilising grade filter must be:
A. Heated
B. Painted
C. Sterilised
D. Disconnected
ANSWER – C
Question 42. Microbial monitoring of gas used in aseptic processing should be performed:
A. Never
B. Only at installation
C. Periodically at point of use
D. Only after a deviation
ANSWER – C
Question 43. Backflow risk from vacuum systems must be prevented by:
A. Employee training
B. Cooling the lines
C. Mechanisms preventing backflow
D. Increasing vacuum strength
ANSWER – C
Question 44. Equipment associated with heating/cooling systems should be located:
A. Inside the filling room
B. Next to product contact surfaces
C. Outside the filling room
D. Near exit doors
ANSWER – C
Question 45. Controls must exist for heating/cooling systems to contain:
A. Temperature drift
B. System fluids and spillage
C. Employee access
D. Electrical usage
ANSWER – B
Question 46. Leaks in hydraulic or cooling systems must be:
A. Ignored if small
B. Painted over
C. Detectable
D. Repaired only annually
ANSWER – C
Question 47. A suitable mechanism to prevent contamination from utilities is:
A. Flow meters
B. Backflow preventers
C. Color indicators
D. Larger pipes
ANSWER – B
Question 48. One key design consideration for water systems is:
A. Creating dead legs
B. Ensuring sloped piping
C. Increasing holding times
D. Eliminating circulation
ANSWER – B
Question 49. A utility that “otherwise directly impacts the product” is considered:
A. High risk
B. Low risk
C. Medium risk
D. No risk
ANSWER – A
Question 50. Water system alert levels should be based on:
A. Industry averages
B. Historical manufacturing deviations only
C. Initial qualification data, requalification data, and ongoing monitoring
D. Auditor preference
ANSWER – C
Question 51. Controls applied to utility systems should be based on:
A. Cost of equipment
B. Auditor preference
C. Risk to product quality
D. Operator experience
ANSWER – C
Question 52. The risk associated with utilities must be documented as part of the:
A. Environmental Monitoring Plan
B. Contamination Control Strategy (CCS)
C. Change Control
D. Training Matrix
ANSWER – B
Question 53. Which utility is considered high risk?
A. Office HVAC
B. Electrical power cables
C. Water directly contacting product
D. Lighting utilities
ANSWER – C
Question 54. Utilities contacting materials that become part of the product are considered:
A. Low risk
B. No risk
C. High risk
D. Medium risk
ANSWER – C
Question 55. Utilities that contact surfaces which contact product are considered:
A. High risk
B. Low risk
C. No risk
D. Negligible risk
ANSWER – A
Question 56. Utilities must be designed, qualified, and maintained to:
A. Minimize installation costs
B. Function as expected
C. Reduce downtime only
D. Meet ergonomic requirements
ANSWER – B
Question 57. High-risk utility critical parameters should undergo:
A. Daily calibration
B. Trending as needed
C. Regular trend analysis
D. No trend analysis
ANSWER – C
Question 58. Utility installation records must include:
A. Employee names
B. Current drawings and specifications
C. Vendor financial details
D. Cleaning logs
ANSWER – B
Question 59. Pipeline records include all EXCEPT:
A. Flow direction
B. Pipe slopes
C. Pipe color
D. Pipe diameter and length
ANSWER – C
Question 60. Pipes and ducts should not be present in cleanrooms unless:
A. They are unavoidable
B. They are new
C. They are easy to hide
D. They are stainless steel
ANSWER – A
Question 61. If pipes are unavoidable in cleanrooms, they must be installed to:
A. Allow easy painting
B. Avoid recesses and difficult-to-clean surfaces
C. Maximize space usage
D. Allow operator access
ANSWER – B
Question 62. Water systems must be designed to prevent:
A. Temperature rise
B. Operator error
C. Microbiological contamination
D. High conductivity
ANSWER – C
Question 63. Water treatment systems should minimize:
A. Mechanical wear
B. Microbial contamination and endotoxin formation
C. Water pressure
D. Filter differential pressure
ANSWER – B
Question 64. Filters within water systems require:
A. No maintenance
B. Monthly replacement
C. Special attention to monitoring and maintenance
D. Color coding
ANSWER – C
Question 65. Water produced must comply with:
A. Marketing claims
B. Current monograph of relevant Pharmacopeia
C. Supplier recommendations
D. Historic standards
ANSWER – B
Question 66. Water systems must be qualified and validated to maintain:
A. Microbial control only
B. Physical, chemical, and microbial control
C. Temperature control only
D. Pressure stability
ANSWER – B
Question 67. Seasonal variations must be considered in:
A. Routine maintenance
B. Qualification and validation
C. Decommissioning
D. Procurement
ANSWER – B
Question 68. Turbulent flow in water systems minimizes:
A. Foaming
B. Pressure drops
C. Microbial adhesion and biofilm formation
D. Energy consumption
ANSWER – C
Question 69. Flow rates for water systems must be:
A. Guessed based on usage
B. Established during qualification and routinely monitored
C. Based on supplier documents only
D. Checked only annually
ANSWER – B
Question 70. WFI must be circulated at:
A. Below 20°C
B. Room temperature
C. Above 70°C
D. Between 30–40°C
ANSWER – C
Question 71. WFI may be produced by distillation or by:
A. Sand filtration alone
B. Reverse osmosis with additional techniques
C. UV treatment only
D. Boiling
ANSWER – B
Question 72. WFI vent filters must be:
A. Cleaned with alcohol
B. Integrity tested before installation and after use
C. Replaced monthly
D. Stored at ambient temperature
ANSWER – B
Question 73. Condensation on vent filters must be prevented by:
A. Cooling the filter
B. Heating the filter
C. Spraying disinfectant
D. Increasing airflow
ANSWER – B
Question 74. Water system sterilization/disinfection must follow:
A. Operator judgement
B. A predetermined schedule
C. Seasonal planning only
D. Weekly scheduling
ANSWER – B
Question 75. Chemical disinfection must be followed by:
A. Visual inspection
B. Validated rinsing/flushing
C. Immediate system start-up
D. Pressure testing only
ANSWER – B
Question 76. Water may be returned to use only after:
A. Temperature testing
B. Chemical testing approval + microbial/endotoxin compliance
C. Operator approval
D. Vendor notification
ANSWER – B
Question 77. Ongoing monitoring of water systems includes:
A. Chemical and microbial monitoring
B. Pressure monitoring only
C. Temperature spot checks
D. Operator logs
ANSWER – A
Question 78. Alert levels should be based on:
A. Industry averages
B. Initial qualification and subsequent monitoring data
C. Last year’s audit report
D. Supplier recommendations
ANSWER – B
Question 79. Sampling programmes must include:
A. Tanks only
B. All outlets and points of use
C. One outlet selected randomly
D. Only points with highest flow
ANSWER – B
Question 80. Sample plans must include at least one sample:
A. Per month
B. Per manufacturing shift
C. Per day that water is used
D. Every hour
ANSWER – C
Question 81. Alert level excursions require:
A. Immediate shutdown
B. Documentation and review
C. No action
D. Filter replacement only
ANSWER – B
Question 82. Action limit excursions require investigation of:
A. Employee competence
B. Root cause and product impact
C. Market complaints
D. Training records
ANSWER – B
Question 83. WFI systems should include continuous monitoring for:
A. UV absorbance
B. Color
C. TOC and conductivity
D. Viscosity
ANSWER – C
Question 84. Sensor locations for WFI monitoring must be based on:
A. Cost
B. Operator preference
C. Risk
D. Convenience
ANSWER – C
Question 85. Pure steam generator feed water must be:
A. Softened only
B. Appropriately purified
C. Derived from municipal water directly
D. UV treated only
ANSWER – B
Question 86. Pure steam must meet defined:
A. pH limits only
B. Chemical and endotoxin limits
C. Pressure ranges only
D. Flow rates only
ANSWER – B
Question 87. Condensate from pure steam must meet monograph requirements for:
A. Potable water
B. Water for injection (WFI)
C. Sterile water for irrigation
D. Cold water
ANSWER – B
Question 88. Microbial testing of steam condensate is:
A. Mandatory
B. Not mandatory
C. Performed weekly
D. Not allowed
ANSWER – B
Question 89. Pure steam quality is periodically assessed using parameters including:
A. TOC levels only
B. Conductivity
C. Non-condensable gases, dryness value, superheat
D. Microbial count
ANSWER – C
Question 90. Gases contacting product must meet:
A. Odor requirements only
B. Chemical, particulate & microbial quality requirements
C. Pressure consistency
D. Only microbial requirements
ANSWER – B
Question 91. Gas quality specifications must consider:
A. Type and use of gas
B. Room size
C. Employee shift patterns
D. Operator convenience
ANSWER – A
Question 92. Gases used in aseptic processing must be filtered using:
A. 1.0 µm filters
B. 0.45 µm filters
C. 0.22 µm sterilising grade filters
D. 5.0 µm filters
ANSWER – C
Question 93. Filters used for gases on a batch basis must be:
A. Painted
B. Integrity tested and results reviewed at batch release
C. Used indefinitely
D. Washed with water
ANSWER – B
Question 94. Pipework after the final sterilising grade filter must be:
A. Labeled
B. Sterilised
C. Painted
D. Replaced monthly
ANSWER – B
Question 95. Microbial monitoring of gas used in aseptic processing should occur:
A. Never
B. Only during installation
C. Periodically at point of use
D. Only during deviations
ANSWER – C
Question 96. Backflow risks in vacuum/pressure systems must be prevented by:
A. Administrative controls
B. Backflow prevention mechanisms
C. Operator awareness
D. Using wider pipes
ANSWER – B
Question 97. Heating and cooling equipment should be located:
A. Inside the filling room
B. In the warehouse
C. Outside the filling room
D. Near product-contact areas
ANSWER – C
Question 98. Heating/cooling systems must have controls to contain:
A. Temperature fluctuations
B. Spillage or cross contamination of system fluids
C. Vibration
D. Steam leaks only
ANSWER – B
Question 99. Leaks from hydraulic or cooling systems should be:
A. Covered
B. Painted
C. Detectable
D. Ignored if small
ANSWER – C
Question 100. A system to detect leaks from heating/cooling equipment may include:
A. Pressure gauges
B. An indication system for leakage
C. Temperature probes
D. Manual inspections only
ANSWER – B