Personnel in clean areas WHO GMP
Questions 1. In clean areas, the number of personnel present should be:
A. As many as possible
B. Only the minimum required
C. Determined by convenience
D. Twice the normal staff
Answer: B
Questions 2. During aseptic processes, inspections and controls should be conducted:
A. Only from inside the clean area
B. As far as possible from outside the clean area
C. By all staff regardless of area
D. Without any supervision
Answer: B
Questions 3. All personnel in clean areas should receive training in:
A. Marketing strategies
B. Hygiene and basic microbiology relevant to sterile products
C. Financial management
D. Packaging design
Answer: B
Questions 4. Outside staff not trained in sterile manufacturing (e.g., contractors) should:
A. Be allowed unrestricted access
B. Receive instruction and supervision
C. Work alone
D. Be ignored
Answer: B
Questions 5. Staff engaged with animal-tissue materials or other microorganism cultures should:
A. Enter sterile-product areas freely
B. Follow rigorous decontamination procedures before entry
C. Wear normal clothing
D. Avoid hand washing
Answer: B
Questions 6. Personnel involved in sterile manufacturing should report:
A. Any illness or condition causing abnormal contaminant shedding
B. Only equipment malfunctions
C. Weather changes
D. Packaging defects
Answer: A
Questions 7. Periodic health checks for personnel in clean areas are:
A. Not required
B. Desirable
C. Mandatory every hour
D. Only for management staff
Answer: B
Questions 8. Changing and washing procedures should:
A. Be informal
B. Minimize contamination of clothing and clean areas
C. Allow outdoor clothes in clean areas
D. Be skipped if staff is experienced
Answer: B
Questions 9. Outdoor clothing should:
A. Be worn over clean-area clothing
B. Not be brought into changing rooms for Grade B and C areas
C. Be left inside Grade A rooms
D. Be sterilized weekly
Answer: B
Questions 10. For Grade A/B areas, gloves and masks should be:
A. Optional
B. Changed at least every working session
C. Worn once per week
D. Shared among operators
Answer: B
Questions 11. Operators in Grade A and B areas should wear:
A. Casual clothing
B. Sanitized goggles
C. Watches
D. Jewelry
Answer: B
Questions 12. Wrist-watches, cosmetics, and jewellery in clean areas:
A. Are permitted in Grade D only
B. Should not be worn
C. Are mandatory
D. Are optional
Answer: B
Questions 13. In Grade D areas, personnel should wear:
A. One-piece jumpsuits
B. Hair, beard, and moustache covered, with protective clothing and shoes/overshoes
C. Casual clothing
D. Sterile gloves only
Answer: B
Questions 14. In Grade C areas, personnel should wear:
A. One-piece jumpsuit, gathered at wrists, high neck, appropriate shoes/overshoes
B. Normal office attire
C. Only gloves and mask
D. Outdoor clothing
Answer: A
Questions 15. Clothing in Grade C areas should:
A. Shed fibers and particulate matter freely
B. Shed virtually no fibers or particulate matter
C. Be made of cotton only
D. Be optional
Answer: B
Questions 16. For Grades A and B, entry of personnel should be:
A. Encouraged freely
B. Minimized
C. Unlimited
D. Determined by convenience
Answer: B
Questions 17. Headgear in Grade A areas should:
A. Partially cover hair
B. Totally enclose hair, beard, and moustache
C. Be optional
D. Be replaced by a cap
Answer: B
Questions 18. For Grades A/B, protective clothing should:
A. Retain particles shed by the body
B. Shed many fibers
C. Be casual clothing
D. Be used once and discarded
Answer: A
1Questions 9. Gloves in Grade A/B areas should be:
A. Sterilized, non-powdered, and appropriate for the material
B. Optional
C. Shared between operators
D. Only disinfected monthly
Answer: A
Questions 20. Trouser-bottoms and garment sleeves in Grade A/B areas should be:
A. Tucked into footwear and gloves
B. Left outside
C. Rolled up
D. Optional
Answer: A
Questions 21. Clothing in clean areas should be laundered or cleaned:
A. Casually, with regular laundry
B. To avoid gathering additional particulate contaminants
C. Once per month
D. Only after visible dirt appears
Answer: B
Questions 22. Separate laundry facilities for clean-area clothing are:
A. Desirable
B. Unnecessary
C. Mandatory by law
D. Forbidden
Answer: A
Questions 23. Damaged fibers in clean-area clothing can:
A. Reduce contamination
B. Increase the risk of particle shedding
C. Have no effect
D. Improve cleanliness
Answer: B
Questions 24. Washing and sterilization of clean-area clothing should follow:
A. Informal methods
B. Standard operating procedures (SOPs)
C. Personal preference
D. Weekly random checks
Answer: B
Questions 25. Personnel training should be:
A. Only initial
B. Both initial and regular
C. Only for management
D. Only for cleaning staff
Answer: B
Questions 26. Minimum personnel in clean areas helps to:
A. Reduce noise
B. Minimize microbial contamination
C. Save on salaries
D. Increase productivity
Answer: B
Questions 27. Gloves in clean areas should be disinfected:
A. Only before starting work
B. Regularly during operations
C. Once a week
D. Not required
Answer: B
Questions 28. Personnel working in Grade A/B areas should wear:
A. Sterilized footwear
B. Non-sterile sneakers
C. Outdoor boots
D. Casual shoes
Answer: A
Questions 29. In clean areas, the action regarding personnel introducing microbial hazards should be decided by:
A. The operator themselves
B. A designated competent person
C. Any available staff
D. External consultants only
Answer: B
Questions 30. Masks in Grade A/B areas are worn to:
A. Keep operators warm
B. Prevent shedding of droplets
C. Improve visibility
D. Reduce fatigue
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products