Terminally Sterilized Products WHO GMP
Question 1. Components for terminally sterilized products should be prepared in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Question 2. Preparation should occur in Grade C when the product:
A. Has low microbial risk
B. Is stable for long storage
C. Actively supports microbial growth
D. Is a solid tablet
Answer: C
Question 3. Long holding times before sterilization require preparation in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 4. Products processed mainly in open vessels require preparation in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 5. Filling of terminally sterilized products should generally be done in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 6. If filling operation is unusually slow, filling should be done in:
A. Grade D
B. Grade C
C. Grade B
D. Grade A with Grade C background
Answer: D
Question 7. Wide-necked containers require filling in:
A. Grade A with Grade C background
B. Grade B
C. Grade D
D. Grade A with Grade B background
Answer: A
Question 8. Terminally sterilized ointments should be prepared and filled in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 9. Terminally sterilized creams should be prepared in:
A. Grade D
B. Grade C
C. Grade B
D. Grade A
Answer: B
Question 10. Suspensions for terminal sterilization must be handled in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Aseptic Preparation
Question 11. Components after washing should be handled in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Question 12. Handling sterile starting materials that will NOT be sterilized later must occur in:
A. Grade A with Grade B background
B. Grade C
C. Grade D
D. Grade C with Grade D background
Answer: A
Question 13. Solutions to be sterile filtered should be prepared in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D only
Answer: C
Manufacture of Sterile Preparations WHO GMP
Question 14. Solutions in a closed system may be prepared in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Question 15. If a solution will NOT be sterile-filtered, preparation must be in:
A. Grade C
B. Grade D
C. Grade A with Grade B background
D. Grade C with Grade B background
Answer: C
Question 16. Aseptic filling must occur in:
A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: C
Question 17. Handling exposed sterile equipment must occur in:
A. Grade B only
B. Grade C
C. Grade A with Grade B background
D. Grade D
Answer: C
Question 18. Transfer of partially closed lyophilization containers may be done in sealed trays in:
A. Grade A only
B. Grade B
C. Grade C
D. Grade D
Answer: B
Question 19. Transfer of partially stoppered containers may occur in:
A. Grade A with Grade B background
B. Grade C
C. Grade D
D. Grade A only
Answer: A
Question 20. Preparation of sterile ointments NOT subsequently filtered must occur in:
A. Grade C
B. Grade A with Grade B background
C. Grade D
D. Grade B only
Answer: B
Processing
Question 21. Contamination control must occur during:
A. Only aseptic stages
B. Only sterilization
C. All processing stages
D. Only filling stages
Answer: C
Question 22. Preparations containing live microorganisms should:
A. Be made in the same area as all products
B. Not be made in areas used for other products
C. Be made only in Grade D
D. Be made only in open systems
Answer: B
Question 23. Use of multiproduct facilities for live organisms is permitted if:
A. Rooms are large
B. Decontamination is validated
C. Personnel are trained
D. Production schedule requires it
Answer: B
Question 24. Vaccines of dead organisms may be dispensed with other products if:
A. Sterility testing is waived
B. Inactivation is validated
C. Made in Grade A
D. Done in a closed system
Answer: B
Question 25. Aseptic processing validation requires:
A. Endotoxin testing
B. Process simulation (media fill)
C. Pressure mapping
D. Water testing only
Answer: B
Question 26. Selection of nutrient media should consider:
A. Cost only
B. Dosage form and clarity
C. Operator preference
D. Filter color
Answer: B
Question 27. Process simulation must mimic:
A. Only easy operations
B. Only final filtration
C. Routine aseptic steps
D. Packaging only
Answer: C
Question 28. Process simulations should avoid:
A. Any risk of contamination
B. Routine steps
C. Cleaning
D. Personnel monitoring
Answer: A
Question 29. Number of required consecutive successful media fills:
A. One
B. Two
C. Three
D. Five
Answer: C
Question 30. Media fills must be repeated:
A. Annually only
B. After major HVAC, process, or equipment changes
C. Only when management requires
D. Only after contamination events
Answer: B
Question 31. Media fills should include:
A. Worst-case interventions
B. Only normal operations
C. Only automated steps
D. Only shift start-up
Answer: A
Question 32. Media fills must represent:
A. Only day shift
B. All shifts and shift changes
C. Only night shift
D. Only weekends
Answer: B
Question 33. For small batches (<5000 units), number of acceptable contaminated units:
A. Zero
B. One
C. Two
D. Three
Answer: A
Question 34. For batches of 5000–10,000 units, one contaminated unit requires:
A. No action
B. Investigation
C. Batch rejection
D. Shutdown
Answer: B
Question 35. For 5000–10,000 units, two contaminated units require:
A. No action
B. Retesting
C. Revalidation
D. Product release
Answer: C
Question 36. For >10,000 units, one contaminated unit requires:
A. Immediate revalidation
B. Investigation
C. No action
D. Batch rejection
Answer: B
Question 37. For >10,000 units, two contaminated units require:
A. Revalidation
B. No investigation
C. Batch release
D. Documentation only
Answer: A
Question 38. Intermittent contaminated units may indicate:
A. Equipment vibration
B. Low-level contamination
C. Operator fatigue
D. High humidity
Answer: B
Question 39. Gross failures require investigation of:
A. Only the failed run
B. All batches since last successful media fill
C. Only future batches
D. Only previous shift
Answer: B
Question 40. Validation must not:
A. Be documented
B. Use nutrient media
C. Compromise processes
D. Include interventions
Answer: C
Question 41. Water systems should be tested for:
A. Only pH
B. Only appearance
C. Chemicals, microbes, and endotoxins
D. Only bioburden
Answer: C
Question 42. Water monitoring records must include:
A. Cost of analysis
B. External audit results
C. Test results and actions taken
D. Gowning logs
Answer: C
Question 43. Activities in clean areas should be:
A. Maximized
B. Minimal
C. Rapid and vigorous
D. Unrestricted
Answer: B
Question 44. Movement of personnel should be:
A. Quick
B. Random
C. Controlled and methodical
D. Frequent
Answer: C
Question 45. Personnel should be excluded from:
A. Grade D
B. Grade C
C. Grade B
D. Grade A zones
Answer: D
Question 46. Temperature and humidity should:
A. Be very high
B. Not be considered
C. Be kept low to avoid personnel discomfort
D. Be random
Answer: C
Question 47. Materials that generate fibers should be:
A. Allowed freely
B. Minimized in clean areas
C. Encouraged to improve airflow
D. Used only in Grade A
Answer: B
Question 48. Fiber-generating materials must be avoided completely:
A. During any operation
B. When aseptic work is in progress
C. During HVAC maintenance
D. During gowning
Answer: B
Question 49. Components must be handled after final cleaning in a way that:
A. Minimizes recontamination
B. Saves time
C. Avoids validation
D. Maximizes exposure
Answer: A
Question 50. Stage of processing must be:
A. Optional
B. Known only to QA
C. Properly identified
D. Left unlabelled
Answer: C
Storage, Timing & Sterilization Controls
Question 51. Time between cleaning and sterilization should be:
A. Several days
B. Uncontrolled
C. As short as possible
D. At least one week
Answer: C
Question 52. Time between sterilization and use must be:
A. Unlimited
B. Validated and minimal
C. Determined by operator
D. Ignored
Answer: B
Question 53. Time between solution preparation and filtration must be:
A. As long as possible
B. Uncontrolled
C. As short as possible
D. Set only for some products
Answer: C
Question 54. Maximum permissible solution holding time must consider:
A. Color and odor
B. Composition and storage method
C. Vial size only
D. Personnel preference
Answer: B
Question 55. Any gas used to purge a solution must be passed through:
A. 0.45 μm filter
B. Activated carbon
C. A sterilizing filter
D. A vacuum system
Answer: C
Question 56. Bioburden should be monitored:
A. Once per year
B. Before sterilization
C. After packaging
D. Only at release
Answer: B
Question 57. Bioburden limits must relate to:
A. Equipment age
B. HVAC temperature
C. Sterilization efficiency
D. Operator experience
Answer: C
Question 58. Bioburden assay is required for:
A. Only aseptic products
B. Only terminally sterilized products
C. Both aseptic and terminally sterilized products
D. Only large-volume products
Answer: C
Question 59. With overkill sterilization, bioburden may be monitored:
A. Never
B. Only at release
C. At scheduled intervals
D. Only for first batch
Answer: C
Question 60. For parametric release, bioburden must be considered:
A. A documentation-only step
B. An in-process test
C. Optional
D. Not required
Answer: B
Question 61. Endotoxin levels should be monitored when:
A. Appropriate
B. Never
C. Only for oral products
D. Only when required by operator
Answer: A
Question 61. All solutions, especially large-volume infusions, should be filtered:
A. At the beginning of the process
B. Through a microorganism-retaining filter
C. Only after filling
D. Only during QC
Answer: B
Question 62. Microorganism-retaining filter should be located:
A. At manufacturing start
B. Immediately before filling
C. In warehouse
D. In administration area
Answer: B
Question 63. Articles required in a clean area during aseptic work should be:
A. Stored at room temperature only
B. Sterilized
C. Placed on open shelves
D. Not sterilized
Answer: B
Question 64. Items should enter aseptic areas through:
A. A single door
B. Any open window
C. Double-ended sterilizers
D. Personnel airlocks
Answer: C
Question 65. Double-ended sterilizers must be:
A. Double-walled
B. Sealed into the wall
C. Portable
D. Used only for packaging
Answer: B
Question 66. Other procedures preventing contamination entry may be:
A. Ignored
B. Acceptable in some cases
C. Not allowed
D. Required always
Answer: B
Question 67. New processing procedures must be:
A. Implemented without testing
B. Validated
C. Used without documentation
D. Exempt from revalidation
Answer: B
Question 68. Validation should be repeated after:
A. Product packaging
B. Routine maintenance
C. Significant process or equipment change
D. Personnel changes
Answer: C
Question 69. Solutions should be filtered:
A. Only when batches are large
B. Only if convenient
C. To reduce particulates
D. Through microorganism-retaining filters
Answer: D
Question 70. Products at unusual risk due to slow filling must be filled in:
A. Grade C
B. Grade B
C. Grade A with Grade C background
D. Grade A with Grade B background
Answer: C
Question 71. Exposed sterile components must be handled in:
A. Grade D
B. Grade C
C. Grade A with Grade B background
D. Grade B with Grade D background
Answer: C
Question 72. Handling sterile materials not sterilized later requires:
A. Grade D
B. Grade A with Grade B background
C. Grade C
D. Grade C with Grade D background
Answer: B
Question 73. Solutions prepared in closed systems may use:
A. Grade A
B. Grade B
C. Grade C
D. Grade D (justifiable)
Answer: D
Question 74. Aseptic filling includes:
A. Nonsterile handling
B. Exposed sterile equipment handling
C. Packaging after sealing
D. Environmental monitoring
Answer: B
Question 75. Partially closed vials before lyophilization completion must be transferred in:
A. Grade B environment using sealed trays
B. Grade D
C. Grade C
D. Any environment
Answer: A
Question 76. Sterile emulsions must be prepared in:
A. Grade C
B. Grade D
C. Grade A with Grade B background
D. Any clean area
Answer: C
Question 77. Containment for live microorganisms must be:
A. Minimal
B. Demonstrated and validated
C. Unnecessary
D. Based on operator judgment
Answer: B
Question 78. Dead organism vaccines may share facilities if:
A. Sterility test passes
B. Inactivation is validated
C. They are filled quickly
D. Only QA approves
Answer: B
Question 79. Media fills must simulate:
A. Only mixing
B. Typical and worst-case operations
C. Only routine filtration
D. Only closing operations
Answer: B
Question 80. Media fills should NOT include:
A. Interventions
B. Activities likely to introduce contamination
C. Filling steps
D. Routine actions
Answer: B
Question 81. At least three consecutive successful media fills ensure:
A. Equipment qualification
B. Validation of aseptic process
C. Personnel training
D. Sterilizer calibration
Answer: B
Question 82. Media fills must be repeated after:
A. Administrative changes
B. Major HVAC modification
C. Lunch break
D. Cleaning
Answer: B
Question 83. Number of containers for media fill must be:
A. Arbitrary
B. Large enough for valid evaluation
C. Minimal
D. Equivalent to 10 units
Answer: B
Question 84. Growth target for media fills is:
A. <5 CFU
B. <1 CFU
C. Zero growth
D. <10 CFU
Answer: C
Question 85. Intermittent failures suggest:
A. Proper sterilization
B. Low-level contamination
C. Equipment overload
D. Poor packaging
Answer: B
Question 86. Gross failure investigations include:
A. Future batches only
B. All batches since last successful fill
C. Only contaminated vials
D. Operator review only
Answer: B
Question 87. Validation should:
A. Never be repeated
B. Not compromise processes
C. Replace sterilization
D. Replace media fills
Answer: B
Question 88. Water testing monitors:
A. pH only
B. Only conductivity
C. Chemicals, biological contamination, endotoxins
D. Only microorganisms
Answer: C
Question 89. Records must include:
A. Only final summaries
B. Test results and corrective actions
C. Employee evaluations
D. Floor plan
Answer: B
Question 90. Personnel movement affects:
A. HVAC settings
B. Particle shedding
C. Equipment noise
D. Lighting
Answer: B
Question 91. Fiber-generating items must be:
A. Used frequently
B. Minimized
C. Encouraged for airflow
D. Required in Grade A
Answer: B
Question 92. After cleaning, components must avoid:
A. Recontamination
B. Rapid drying
C. Labeling
D. Documentation
Answer: A
Question 93. Processing stage identification prevents:
A. Delays
B. Recontamination and mix-ups
C. Sterility
D. Personnel errors only
Answer: B
Question 94. Holding times must be:
A. Long
B. Unspecified
C. As short as possible
D. Determined by batch size
Answer: C
Question 95. Gas used during processing should be:
A. Ventilated outdoors
B. Treated with HEPA filters
C. Passed through sterilizing filters
D. Used unfiltered
Answer: C
Question 96. Bioburden is tested:
A. After filling only
B. Before sterilization
C. During cleaning
D. Only once per year
Answer: B
Question 97. Endotoxin monitoring is required:
A. For all products
B. Where appropriate
C. Only for oral products
D. Only when batches fail sterility
Answer: B
Question 98. Article transfer into clean areas should use:
A. Airlocks only
B. Double-ended sterilizers
C. Windows
D. Manual delivery through doors
Answer: B
Question 99. Revalidation is required when:
A. Personnel changes shifts
B. Any significant equipment or process change occurs
C. On weekends
D. After batch release
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products