Sterilization WHO GMP
Question 1. Preferred sterilization method for sterile products is:
A. Filtration
B. Aseptic filling only
C. Terminal heat sterilization in final container
D. UV irradiation
Answer: C
Question 2. Terminal heat sterilization may be avoided when the product:
A. Is too expensive
B. Is unstable to heat
C. Is stored in glass containers
D. Has low viscosity
Answer: B
Question 3. An alternative sterilization method may be used when:
A. The pack type is incompatible with heat
B. The batch is small
C. The product is a tablet
D. The pH is above 7
Answer: A
Question 4. A plastic eye-dropper bottle is an example of:
A. A heat-stable container
B. A pack type incompatible with heat
C. A preferred container for dry heat
D. A container suitable for UV sterilization
Answer: B
Question 5. UV irradiation is:
A. A recommended method of sterilization
B. Acceptable only for viscous solutions
C. Not normally acceptable for sterilization
D. Equivalent to ionizing radiation
Answer: C
Question 6. Sterilization can be achieved by all except:
A. Dry heat
B. Moist heat
C. Ionizing radiation
D. Standard UV light
Answer: D
Question 7. Preferred method of sterilization when practical:
A. Ethylene oxide
B. Heat sterilization
C. Filtration
D. UV exposure
Answer: B
Question 8. Sterilization method selection must align with:
A. Operator preference
B. Manufacturing and marketing authorizations
C. Local weather conditions
D. Container color
Answer: B
Question 9. Starting materials should have:
A. High bioburden
B. Minimal microbial contamination
C. No microbiological testing
D. Only endotoxin testing
Answer: B
Question 10. Bioburden in starting materials should be:
A. Assumed acceptable
B. Monitored before sterilization
C. Tested only after sterilization
D. Ignored unless a failure occurs
Answer: B
Terminally Sterilized Products WHO GMP
Question 11. Sterilization processes should be:
A. Avoided
B. Skipped for stable products
C. Validated
D. Only visually inspected
Answer: C
Question 12. Extra attention in validation is needed when:
A. The method matches pharmacopoeial standards
B. Using non-pharmacopoeial methods
C. Product is an aqueous solution
D. Batch sizes are small
Answer: B
Question 13. Sterilization of colloidal suspensions requires:
A. No validation
B. Less testing
C. Extra validation
D. Only pH adjustment
Answer: C
Question 14. Before adopting any sterilization process, suitability must be shown by:
A. Seller opinions
B. Physical measurements and biological indicators
C. Label review only
D. Color comparison
Answer: B
Question 15. Verification of sterilization validity must occur:
A. Daily
B. At least annually
C. Every 10 years
D. Only during installation
Answer: B
Question 16. Process re-validation should occur when:
A. QA staff changes
B. Minor cleaning occurs
C. Significant equipment modifications occur
D. New labels are printed
Answer: C
Question 17. Effective sterilization requires:
A. Partial exposure to treatment
B. Cooling before sterilization
C. The whole material exposed to required conditions
D. Only exposure of the container exterior
Answer: C
Question 18. Biological indicators are:
A. The primary method of control
B. Optional and only supplementary
C. Unnecessary
D. A guarantee of sterility
Answer: B
Question 19. Biological indicators must be:
A. Stored at room temperature always
B. Used without controls
C. Stored and used as per manufacturer instructions
D. Reused after sterilization
Answer: C
Question 20. Biological indicators’ quality should be checked using:
A. Negative controls
B. Positive controls
C. Operator judgement
D. Visual inspection
Answer: B
Question 21. When using biological indicators, precautions must avoid:
A. Heat exposure
B. Pressure changes
C. Transfer of microbial contamination from them
D. Condensation
Answer: C
Question 22. There must be a clear means of differentiating between:
A. Glass and plastic containers
B. Sterilized and non-sterilized products
C. Liquid and solid products
D. Expired and accepted batches
Answer: B
Question 23. Product carriers should be labelled with all except:
A. Batch number
B. Material name
C. Production operator name
D. Sterilization status
Answer: C
Question 24. Autoclave tape may be used to indicate:
A. Sterility guarantee
B. Whether a batch has passed through sterilization
C. Temperature uniformity
D. Container integrity
Answer: B
Question 25. Autoclave tape cannot:
A. Show exposure to a process
B. Confirm sterility
C. Adhere to metal trays
D. Change color
Answer: B
Question 26. Loading patterns for sterilization must be:
A. Chosen daily by operators
B. Validated
C. Random
D. Based on container color
Answer: B
Question 27. Sterilization records must be available for:
A. Only the first run
B. Each sterilization run
C. Only failed runs
D. Only large batches
Answer: B
Question 28. Sterilization records are reviewed as part of:
A. Cleaning procedures
B. Batch-release procedure
C. Operator performance review
D. Storage management
Answer: B
Question 29. Validation should be done when using methods for:
A. Simple solutions
B. Non-standard or complex products
C. Standard, approved drugs
D. Only heat-stable items
Answer: B
Question 30. The sterilization process must ensure:
A. Only outer surfaces are sterilized
B. Only container integrity is maintained
C. Treatment reaches all parts of the load
D. Only vapor contact occurs
Answer: C
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products