Premises WHO GMP
Questions 1. Grade A and B areas should be designed so that operations can be:
A. Conducted only by supervisors
B. Observed from outside
C. Hidden from view
D. Monitored by external cameras only
Answer: B
Questions 2. All exposed surfaces in clean areas should be:
A. Rough and porous
B. Smooth, impervious, and unbroken
C. Painted with any coating
D. Wooden or fabric-covered
Answer: B
Questions 3. To reduce dust accumulation, clean areas should have:
A. Many ledges and shelves
B. No uncleanable recesses and minimal projections
C. Hanging wires and pipes
D. Open storage spaces
Answer: B
Questions 4. Doors in clean areas should:
A. Be sliding to save space
B. Open to the high-pressure side and have self-closers
C. Swing randomly
D. Be left open during operations
Answer: B
Questions 5. False ceilings should be:
A. Open for ventilation
B. Sealed to prevent contamination from void space above
C. Painted with water-based paint
D. Made of wood
Answer: B
Questions 6. Pipes, ducts, and utilities should be installed to:
A. Create recesses for airflow
B. Avoid uncleanable openings and surfaces
C. Maximize dust accumulation
D. Use threaded connections freely
Answer: B
Questions 7. Sinks and drains in Grade A/B areas should:
A. Be installed wherever convenient
B. Be avoided wherever possible
C. Be placed inside the critical zone
D. Be shared by multiple rooms
Answer: B
Questions 8. Floor channels should be:
A. Hidden under equipment
B. Open, easily cleanable, and connected to drains outside the area
C. Covered with mats
D. Connected directly to other clean areas
Answer: B
Questions 9. Changing rooms should:
A. Allow direct entry from outside
B. Be designed as airlocks for physical separation and contamination control
C. Be combined with work areas
D. Have open windows for ventilation
Answer: B
Questions 10. The final stage of a changing room should:
A. Be lower in grade than the clean area it leads to
B. Match the grade of the area it leads to
C. Be arbitrary
D. Always be Grade D
Answer: B
Questions 11. Airlock doors should:
A. Be opened simultaneously for convenience
B. Not be opened simultaneously; interlocking and warning systems should be used
C. Have no interlocking
D. Be locked at all times
Answer: B
Questions 12. Positive pressure in clean areas is maintained by:
A. Open windows
B. A filtered air supply
C. Air-conditioning only
D. Ceiling fans
Answer: B
Questions 13. Pressure differential between adjacent rooms of different grades should be:
A. Approximately 1–2 Pascals
B. Approximately 10–15 Pascals
C. Zero
D. Unimportant
Answer: B
Questions 14. Airflow patterns should be designed to:
A. Move particles from low-risk zones to high-risk zones
B. Avoid contamination risk by preventing particle transfer to higher product-risk zones
C. Generate turbulence for cooling
D. Be unpredictable
Answer: B
Questions 15. Access to critical filling areas (e.g., Grade A zones) should be:
A. Unrestricted for all personnel
B. Restricted using physical barriers where possible
C. Open for maintenance staff
D. Controlled only by visual inspection
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products