Personnel EUGMP- Annex-1
Question 1. The manufacturer must ensure there are sufficient personnel who are:
A. Newly hired
B. Qualified, trained, and experienced
C. Working part-time
D. Only externally certified
Answer: B
Question 2. Personnel must be trained in the manufacture and testing of:
A. Veterinary products only
B. Sterile products
C. Cosmetics
D. Medical devices
Answer: B
Question 3. Only the ______ number of personnel should be present in cleanrooms.
A. Maximum
B. Minimum
C. Average
D. Undetermined
Answer: B
Question 4. The maximum number of cleanroom operators must be:
A. Estimated verbally
B. Determined and documented
C. Ignored during APS
D. Set by the government
Answer: B
Question 5. Too many personnel in a cleanroom can compromise:
A. Chain of custody
B. Sterility assurance
C. Production scheduling
D. Shift handover
Answer: B
Question 6. Personnel performing cleaning or maintenance must receive:
A. No special training
B. Microbiology degree
C. Regular training and gowning qualification
D. Only PPE
Answer: C
Question 7. Training must include basic elements of:
A. Chemistry
B. Physics
C. Microbiology and hygiene
D. Engineering
Answer: C
Question 8. Personnel entering Grade B or intervening in Grade A must understand:
A. Packaging procedures
B. HVAC maintenance
C. Contamination control and aseptic techniques
D. Procurement procedures
Answer: C
Question 9. Training level should be based on:
A. Salary
B. Seniority
C. Criticality of the function
D. Department
Answer: C
Question 10. Personnel accessing Grade A and B areas must be trained for:
A. Basic gowning only
B. Aseptic gowning and behaviours
C. Laboratory sampling
D. Warehouse hygiene
Answer: B
Question 11. Gowning compliance in Grade A/B must be confirmed by:
A. Opinion
B. Visual and microbial assessment
C. A written test only
D. Annual interview
Answer: B
Question 12. Unsupervised access to Grade A/B is restricted to personnel who:
A. Are senior
B. Passed gowning assessment and participated in a successful APS
C. Are temporary staff
D. Wear extra PPE
Answer: B
Question 13. Unqualified personnel should not enter Grade A or B unless:
A. It is convenient
B. There is an emergency process
C. They work in management
D. Trained operators are busy
Answer: B
Question 14. Unqualified personnel entering Grade A/B must be:
A. Left alone
B. Supervised by an authorized person
C. Allowed to perform any task
D. Given full access immediately
Answer: B
Question 15. Their access must be assessed and recorded as part of:
A. HR records
B. PQS
C. Finance system
D. Warehouse logs
Answer: B
Question 16. Personnel can be disqualified based on:
A. Vacation history
B. Monitoring programme adverse trends
C. Workload
D. Age
Answer: B
Question 17. After disqualification, personnel must undergo:
A. Retraining and requalification
B. Demotion
C. Termination
D. No further action
Answer: A
Question 18. Personal hygiene is essential to prevent:
A. Slippery floors
B. Particle and microbial shedding
C. Long gowning time
D. HR issues
Answer: B
Question 19. Personnel must report health conditions that:
A. Affect eyesight
B. Affect travel capability
C. Increase contamination shedding
D. Affect handwriting
Answer: C
Question 20. Decisions about health-related access restrictions must be made by:
A. HR manager
B. Designated competent person
C. Visitors
D. Security
Answer: B
Question 21. Personnel working with external microorganisms must not enter clean areas unless:
A. They wash hands
B. Defined decontamination procedures are followed
C. They change jobs
D. They are promoted
Answer: B
Question 22. Personal items such as wristwatches and make-up:
A. Are allowed
B. Allowed only in Grade D
C. Are not allowed in any clean area
D. Only allowed during night shift
Answer: C
Question 23. Manufacturer-supplied electronic devices may be allowed if:
A. They are expensive
B. They are small
C. They can be effectively cleaned and disinfected
D. They have touch screens
Answer: C
Question 24. Gowning and hand washing must follow:
A. Verbal traditions
B. Written procedures
C. Operator preference
D. Annual suggestions
Answer: B
Question 25. Clothing must be appropriate to:
A. Shift type
B. Cleanroom grade and process
C. Staff rank
D. Season
Answer: B
Question 26. Garments must be visually checked:
A. Once a year
B. Only after use
C. Before and after gowning
D. Never
Answer: C
Question 27. Sterilised garments must be checked to ensure:
A. They are stylish
B. They match the operator
C. They are within hold time and packaging integrity is intact
D. They feel comfortable
Answer: C
Question 28. Clothing should be chosen to limit:
A. Heat
B. Shedding
C. Colour changes
D. Storage space
Answer: B
Question 29. Grade B gowning requires:
A. No gloves
B. Regular headgear
C. Sterile headgear enclosing all hair
D. Only boots
Answer: C
Question 30. In Grade B, garment sleeves should be tucked:
A. Under the suit
B. Into outer sterile gloves
C. Into trouser legs
D. Outside the gown
Answer: B
Question 31. Grade C clothing includes:
A. Sterile masks
B. Sterile goggles
C. Suit gathered at wrists and high neck
D. Only street clothes
Answer: C
Question 32. Grade D clothing requires:
A. Full sterile suit
B. General protective suit with covered hair
C. No shoes
D. Only gloves
Answer: B
Question 33. Additional gowning in Grade C and D may be needed based on:
A. Overtime
B. Operator age
C. CCS contamination risk
D. Temperature
Answer: C
Question 34. Gowning must be performed in:
A. Cafeteria
B. Grade-appropriate change rooms
C. Warehouse
D. QC lab
Answer: B
Question 35. Outdoor clothing (except underwear) must NOT be brought into:
A. Grade D
B. Change rooms leading to Grade B & C
C. Offices
D. Warehouse
Answer: B
Question 36. Facility socks and suits must:
A. Be colourful
B. Pose no contamination risk
C. Match company logo
D. Be worn over street clothes
Answer: B
Question 37. Each entry into Grade A/B requires:
A. Reusing old gowns
B. Disposable gowns only
C. Clean sterilised garments
D. No mask
Answer: C
Question 38. The maximum gown wearing time must be:
A. Random
B. Determined by garment qualification
C. Operator preference
D. Fixed by law
Answer: B
Question 39. Gloves should be disinfected:
A. Only at shift start
B. Regularly during operations
C. Only when dirty
D. Never
Answer: B
Question 40. Clothing damaged during use must be:
A. Ignored
B. Repaired on the spot
C. Changed immediately
D. Used until shift ends
Answer: C
Question 41. Reusable garments must be laundered in a facility that is:
A. Close to the cafeteria
B. Cheap
C. Adequately segregated from production
D. Located off-site
Answer: C
Question 42. Laundry processes must be:
A. Qualified
B. Uncontrolled
C. Performed manually
D. Optional
Answer: A
Question 43. Garment qualification must include:
A. Branding
B. Colour testing
C. Maximum laundry/sterilisation cycles
D. Employee preference
Answer: C
Question 44. Non-critical activities in clean areas should be:
A. Maximised
B. Performed frequently
C. Kept to a minimum
D. Encouraged
Answer: C
Question 45. Personnel movement should be:
A. Quick and efficient
B. Slow and controlled
C. Relaxed and random
D. Constant
Answer: B
Question 46. Vigorous movement increases:
A. Lighting
B. Productivity
C. Shedding of particles and organisms
D. Air exchange
Answer: C
Question 47. Operators in aseptic operations must avoid disrupting:
A. Water supply
B. Gown storage
C. First air (unidirectional airflow)
D. Waste handling
Answer: C
Question 48. Movement near the critical zone should be:
A. Encouraged
B. Free and unrestricted
C. Restricted
D. Random
Answer: C
Question 49. Obstructing airflow can introduce air of:
A. Lower quality into the critical zone
B. Higher humidity
C. Excess pressure
D. No consequence
Answer: A
Question 50. Airflow visualisation studies should be reviewed as part of:
A. Cleaning scheduling
B. Maintenance planning
C. Operator training
D. Payroll processing
Answer: C