Equipment WHO GMP
Questions 1. A conveyor belt should not pass through a partition between a Grade A/B clean area and a lower-grade processing area unless:
A. The belt is painted regularly
B. The belt is continuously sterilized (e.g., in a sterilizing tunnel)
C. Personnel supervise it constantly
D. The belt is made of stainless steel
Answer: B
Questions 2. Equipment used for processing sterile products should, whenever possible, be chosen so that it can be sterilized by:
A. Steam, dry heat, or other suitable methods
B. Cold water
C. Air only
D. Chemical cleaning without sterilization
Answer: A
Questions 3. Equipment fittings and services should be designed so that:
A. Maintenance can be carried out only inside clean areas
B. Operations, maintenance, and repairs can be carried out outside clean areas
C. Equipment never requires maintenance
D. Operators can adjust equipment freely during processing
Answer: B
Questions 4. Equipment that must be disassembled for maintenance should:
A. Be immediately used without sterilization
B. Be re-sterilized after complete reassembly
C. Be replaced with new equipment
D. Not be used for sterile products again
Answer: B
Questions 5. When maintenance is carried out within a clean area, the area should be:
A. Left as it is
B. Cleaned and disinfected again if cleanliness and asepsis were compromised
C. Only wiped with a dry cloth
D. Closed for one week
Answer: B
Questions 6. All critical equipment (e.g., sterilizers, air-handling systems) should be subject to:
A. Validation and planned maintenance
B. Visual inspection only
C. Cleaning without records
D. Occasional checks by operators
Answer: A
Questions 7. Approval to return equipment to use after maintenance should be:
A. Automatic
B. Required before resuming operations
C. Unnecessary for low-risk equipment
D. Done only verbally
Answer: B
Questions 8. Water-treatment plants and distribution systems should:
A. Be operated beyond their design capacity if needed
B. Ensure a reliable source of water of appropriate quality
C. Use untreated water when necessary
D. Be shut down frequently for cleaning only
Answer: B
Questions 9. Water-treatment plants should include:
A. Testing programs as part of maintenance
B. Random inspections only
C. No quality monitoring
D. Only temperature checks
Answer: A
Questions 10. Water for injection should be stored and circulated to prevent microbial growth by:
A. Constant circulation at a temperature above 70 °C or below 4 °C
B. Keeping it at room temperature
C. Freezing it only
D. Circulation at any temperature
Answer: A
Questions 11. Equipment maintenance outside clean areas helps to:
A. Reduce risk of contamination
B. Increase processing time
C. Increase microbial load
D. Avoid training personnel
Answer: A
Questions 12. Air-handling and filtration systems should be:
A. Validated and maintained according to plan
B. Checked once per decade
C. Operated without records
D. Replaced annually regardless of condition
Answer: A
Questions 13. Equipment used in sterile processing should be designed to:
A. Minimize cleaning and sterilization requirements
B. Be effectively sterilized and maintained
C. Avoid validation
D. Be portable only
Answer: B
Questions 14. Tools and instruments used during maintenance in clean areas should be:
A. Dirty to test cleaning procedures
B. Clean and sterile
C. Made of plastic only
D. Shared without sterilization
Answer: B
Questions 15. Water-treatment and distribution systems should not be:
A. Operated beyond their designed capacity
B. Monitored for quality
C. Maintained regularly
D. Validated for microbial safety
Answer: A
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products