WHO GMP for Sterile Pharmaceutical Products
Clean Areas & Facilities
Question 1. Sterile preparation production should be carried out in:
A. Open manufacturing spaces
B. Controlled warehouses
C. Clean areas
D. Regular production rooms
Answer: C
Question 2. Entry to clean areas should occur through:
A. Free-access doors
B. Airlocks
C. Emergency exits
D. Storage rooms
Answer: B
Question 3. Air supplied to clean areas must pass through:
A. Air-cooling units
B. Filters of required efficiency
C. Humidifiers
D. Dehumidifiers
Answer: B
Question 4. Clean areas must be maintained:
A. At room temperature
B. At a basic hygiene level
C. To an appropriate standard of cleanliness
D. With natural ventilation
Answer: C
Question 5. Component preparation, product preparation, filling, and sterilization should be:
A. Carried out in the same room
B. Performed outside clean areas
C. Conducted in separate areas within the clean area
D. Done only in Grade A areas
Answer: C
Question 6. Clean areas are classified into:
A. Three grades
B. Four grades
C. Five grades
D. Two grades
Answer: B
Types of Manufacturing Operations
Question 7. Manufacturing operations are divided into:
A. Manual and automated processes
B. Packaging and filling
C. Terminal sterilization and aseptic processing
D. Wet and dry operations
Answer: C
Question 8. Terminally sterilized products are:
A. Never tested for sterility
B. Sterilized at the beginning of production
C. Sterilized in their final containers
D. Prepared in open rooms
Answer: C
Pharmaceutical Quality System (PQS)
Question 9. Aseptic processing involves:
A. All stages conducted outside clean rooms
B. No environmental monitoring
C. Maintaining sterility during all or some processing stages
D. Sterilizing the product after packaging
Answer: C
Quality Control – Sterility Testing
Question 10. The sterility test should be regarded as:
A. The main sterility assurance method
B. A replacement for validation
C. The last in a series of control measures
D. Optional
Answer: C
Question 11. The sterility test must be:
A. Performed only once per year
B. Validated for the product
C. Done before validation
D. Conducted only on intermediates
Answer: B
Question 12. Samples for sterility testing must be:
A. Taken only from the end of a batch
B. Only from the easiest-to-access containers
C. Representative of the entire batch
D. Taken from the warehouse
Answer: C
Question 13. For aseptically filled products, samples should include:
A. Only containers from middle of batch
B. First and last filled containers
C. Only containers filled after breaks
D. Only rejects
Answer: B
Question 14. For aseptic filling, samples should also include containers filled:
A. Before sterilization
B. After any significant interruption
C. Only during night shifts
D. After equipment cleaning
Answer: B
Question 15. For heat-sterilized products, samples should consider:
A. Hottest locations
B. Random locations
C. The coolest part of the load
D. Only middle-section containers
Answer: C
Question 16. Sterility of terminally sterilized products is assured by:
A. Visual inspection
B. Container closure integrity only
C. Validation of sterilization cycles
D. Labelling checks
Answer: C
Question 17. Sterility of aseptically processed products is assured by:
A. Repeated sterility testing
B. Media fills (media simulations)
C. Product color inspection
D. Container washing
Answer: B
Question 18. Records to be reviewed with sterility test results for aseptic processing include:
A. Finance records
B. Environmental quality records
C. Packaging invoices
D. Sales documents
Answer: B
Question 19. Pharmacopoeial methods should be used for:
A. Equipment qualification
B. Cleaning validation
C. Sterility test validation and performance
D. Staff training
Answer: C
Question 20. Parametric release may replace:
A. Environmental monitoring
B. Sterility testing
C. Media fills
D. Process validation
Answer: B
Question 21. Parametric release requires special attention to:
A. Marketing studies
B. Operator training
C. Validation and monitoring of the manufacturing process
D. Visual inspection
Answer: C
Endotoxin Monitoring
Question 22. For injectable products, what must be monitored?
A. Only intermediates
B. Endotoxins
C. Only raw materials
D. Only packaging components
Answer: B
Question 23. Endotoxin testing must use:
A. Any convenient method
B. Non-validated methods
C. Validated pharmacopoeial methods
D. Visual checks
Answer: C
Question 24. Large-volume infusion solutions require endotoxin monitoring of:
A. Finished product only
B. Water or intermediates in addition to monograph tests
C. Packaging labels
D. Shipping containers
Answer: B
Question 25. When an endotoxin test fails:
A. Only retesting is required
B. The batch is automatically approved
C. The cause must be investigated
D. The failure is ignored
Answer: C
Question 26. Alternative endotoxin methods may be used if:
A. Cheaper
B. Non-pharmacopoeial and unvalidated
C. Validated, justified, and authorized
D. Recommended by competitors
Answer: C
Rapid Microbiological Methods
Question 27. Rapid microbiological methods may replace traditional methods if:
A. They are faster
B. They are validated and compared to pharmacopoeial methods
C. They require less training
D. They are cheaper
Answer: B
Question 28. Rapid methods may provide earlier results for:
A. Stability tests
B. Marketing studies
C. Water, environmental, or bioburden quality
D. Label printing
Answer: C
Sanitation of Clean Areas
Question 29. Sanitation of clean areas is:
A. Not necessary every day
B. Particularly important
C. Optional in Grade C and D
D. Only required before audits
Answer: B
Question 30. Clean areas should be cleaned:
A. When visibly dirty
B. Only annually
C. Frequently and thoroughly
D. Only after batch failures
Answer: C
Question 31. Cleaning must follow:
A. Operator opinion
B. Oral instructions
C. An approved written programme
D. Marketing documents
Answer: C
Question 32. Use of disinfectants in clean areas should involve:
A. Only one disinfectant
B. Multiple types of disinfectants
C. Unvalidated chemicals
D. Only water
Answer: B
Question 33. Monitoring during sanitation should detect:
A. Electrical hazards
B. Chemical residues
C. Contamination or resistant organisms
D. Broken equipment
Answer: C
Question 34. Interactions between cleaning materials must be:
A. Avoided
B. Ignored
C. Validated
D. Considered optional
Answer: C
Question 35. Cleaning validation must ensure:
A. Operators use gloves
B. Disinfectant residues can be detected and removed
C. Floors shine
D. Documentation looks correct
Answer: B
Disinfectants and Detergents
Question 36. Disinfectants and detergents must be monitored for:
A. pH
B. Microbial contamination
C. Odor
D. Color
Answer: B
Question 37. Dilutions of disinfectants must be kept in:
A. Any container available
B. Previously cleaned containers
C. Open buckets
D. Disposable bags
Answer: B
Question 38. Diluted disinfectants should be stored:
A. Indefinitely
B. Only for defined periods unless sterilized
C. In uncontrolled conditions
D. In personal lockers
Answer: B
Question 39. Disinfectants in Grade A and B areas must be:
A. Filtered
B. Boiled
C. Sterile
D. Colored
Answer: C
Sporicidal Agents & Effectiveness
Question 40. A disinfectant programme should include:
A. Only detergent
B. A sporicidal agent
C. Only water
D. Perfumed disinfectants
Answer: B
Question 41. Why include a sporicidal agent?
A. Spores improve disinfectant activity
B. Most disinfectants are ineffective against spores
C. Spores improve the environment
D. It reduces cost
Answer: B
Question 42. Effectiveness of cleaning must be:
A. Stated but not tested
B. Demonstrated
C. Assumed
D. Ignored
Answer: B
Fumigation
Question 43. Fumigation of clean areas may be useful to:
A. Improve lighting
B. Increase humidity
C. Reduce microbial contamination in inaccessible places
D. Reduce cost
Answer: C
Advanced/Applied Questions
Question 44. Airlocks for personnel and materials help to:
A. Speed up production
B. Prevent unauthorized access
C. Maintain clean area integrity
D. Improve worker comfort
Answer: C
Question 45. Separate operations inside clean areas help:
A. Reduce noise
B. Prevent cross-contamination
C. Save space
D. Increase product color uniformity
Answer: B
Question 46. Media fills simulate:
A. Packaging operations
B. Aseptic processing conditions
C. Cleaning operations
D. Product labeling
Answer: B
Question 47. Environmental quality records include monitoring of:
A. Printing defects
B. Temperature only
C. Microbial and particulate levels
D. Warehouse space
Answer: C
Question 48. A sterility test alone:
A. Guarantees sterility
B. Does NOT guarantee sterility
C. Replaces environmental monitoring
D. Eliminates need for validation
Answer: B
Question 49. Validation of the sterilization process ensures:
A. Correct labeling
B. Reliable destruction of microorganisms
C. Proper color of solution
D. Improved packaging quality
Answer: B
Question 50. Samples from the coolest part of a heat-sterilization load are important because:
A. They cool fastest
B. These locations may be least sterilized
C. They are easiest to access
D. They heat fastest
Answer: B
Question 51. Aseptic process integrity relies heavily on:
A. Equipment color
B. Environmental control
C. Packaging graphics
D. Batch numbering
Answer: B
Question 52. Endotoxin monitoring is conducted on:
A. Finished product only
B. Water for injection, intermediates, and finished product
C. Packaging materials only
D. Any random sample
Answer: B
Question 53. Sporicidal agents are particularly effective against:
A. Viruses
B. Spores
C. Pyrogens
D. Endotoxins
Answer: B
Question 54. Residual disinfectants left on surfaces could:
A. Improve sanitation
B. Increase bioburden
C. Interfere with sterility assurance
D. Aid sterilization
Answer: C
Question 55. Cleaning materials such as detergents must be stored:
A. Without labeling
B. In previously cleaned containers
C. Open to the atmosphere
D. Without expiry dates
Answer: B
Question 56. A validated rapid microbiological method must be:
A. Cheaper than traditional methods
B. Faster and scientifically comparable
C. Uncontrolled
D. Optional regardless of validation
Answer: B
Question 57. Clean areas should be monitored to ensure:
A. Staff comfort
B. Absence of resistant organisms
C. That cleaners complete their shifts
D. Humidity control for equipment
Answer: B
Question 58. Use of multiple disinfectants helps:
A. Avoid resistant microorganisms
B. Reduce cost
C. Improve odor
D. Avoid staff training
Answer: A
Question 59. Fumigation is classified as:
A. A routine cleaning requirement
B. A useful supplemental method
C. A replacement for disinfectants
D. A sterilization method
Answer: B
Question 60. All sterilization and aseptic processing measures aim to:
A. Improve marketing claims
B. Reduce cost of production
C. Assure sterility and prevent contamination
D. Increase shelf-life
Answer: C
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products