Aseptic Preparation and Processing in Pharma EUGMP- Annex-1
Question 1. The aseptic process should be:
A. Informal and flexible
B. Clearly defined
C. Performed without documentation
D. Determined only by production
Answer: B
Question 2. Risks associated with the aseptic process should be:
A. Ignored unless critical
B. Identified, assessed, and controlled
C. Controlled only by QA
D. Evaluated only once
Answer: B
Question 3. Accepted residual risks should be:
A. Verbal only
B. Ignored
C. Formally documented
D. Eliminated completely
Answer: C
Question 4. Precautions to minimize microbial, endotoxin, and particle contamination apply:
A. Only during filtration
B. Only after sterilization
C. During all processing stages before and after sterilization
D. Only during filling
Answer: C
Question 5. Materials that generate particles and fibres should be:
A. Encouraged
B. Minimized
C. Ignored
D. Used freely
Answer: B
Question 6. Use of RABS, isolators, or automation is recommended to:
A. Increase operator contact
B. Reduce need for critical interventions
C. Simplify documentation
D. Eliminate cleaning needs
Answer: B
Question 7. Automated technologies like dry heat tunnels and automated lyophilizer loading help:
A. Increase human interventions
B. Remove need for Grade A
C. Reduce contamination risk
D. Replace sterilization
Answer: C
Question 8. For sterile products that cannot be filtered, all contact equipment must be:
A. Cleaned only
B. Sterilized prior to use
C. Wiped with alcohol
D. Used as received
Answer: B
Question 9. Raw materials or intermediates for non-filterable sterile products should be:
A. Aseptically added without sterilization
B. Sterilized and aseptically added
C. Only inspected
D. Stored in Grade A
Answer: B
Question 10. Unwrapping and assembly of sterilized equipment should occur in:
A. Grade C with Grade D background
B. Grade A with Grade B background
C. Grade B only
D. Grade D
Answer: B
Question 11. Filling of sterile products must occur in:
A. Grade A with Grade B background
B. Grade C with Grade B background
C. Grade D only
D. Grade C with Grade A background
Answer: A
Question 12. Preparation of ointments, creams, suspensions, and emulsions (not filtered or terminally sterilized) should occur in:
A. Grade C
B. Grade D
C. Grade A with Grade B background
D. Outdoors
Answer: C
Question 13. Aseptic connections should be performed in Grade A with Grade B background unless:
A. The process occurs at night
B. They will be sterilized in place or use intrinsic sterile connection devices
C. Operator prefers lower classification
D. Vendor instructions say otherwise
Answer: B
Question 14. Intrinsic sterile connection devices should be designed to:
A. Reduce cost
B. Mitigate contamination risk
C. Increase flexibility
D. Allow manual adjustment
Answer: B
Question 15. Aseptic manipulations should be minimized through:
A. Frequent operator retraining
B. Engineering design solutions and preassembled equipment
C. Increasing interventions
D. Reducing automation
Answer: B
Question 16. Intrinsic sterile connection devices must be:
A. Avoided
B. Randomly selected
C. Appropriately assessed and verified
D. Used only with Grade D
Answer: C
Question 17. There should be an authorized list of:
A. Raw materials only
B. Allowed and qualified interventions
C. Available operators
D. Packaging materials
Answer: B
Question 18. Non-qualified interventions may be used only:
A. When convenient for operators
B. In exceptional circumstances with quality authorization
C. During validation
D. At the end of the shift
Answer: B
Question 19. All interventions should be:
A. Ignored
B. Recorded and fully investigated
C. Discussed verbally
D. Deleted after review
Answer: B
Question 20. Interventions and stoppages must be recorded in:
A. Equipment logbook
B. Batch record
C. Training file
D. Warehouse notes
Answer: B
Question 21. Batch record entries for stoppages should include:
A. Only operator name
B. Time, duration, and operators involved
C. Only duration
D. Only reason
Answer: B
Question 22. Duration of aseptic processing steps should be:
A. Unlimited
B. Minimized and validated
C. Determined by operator
D. Based on equipment availability
Answer: B
Question 23. Holding time between cleaning, drying, and sterilization must be:
A. Arbitrary
B. Defined and validated
C. Operator-dependent
D. Ignored
Answer: B
Question 24. Holding time for sterilized components before use should be:
A. As long as convenient
B. Minimized and validated
C. Unlimited
D. Based on operator discretion
Answer: B
Question 25. Maximum permissible time for product preparation before sterilization must consider:
A. Production schedule
B. Product composition and storage conditions
C. Operator workload
D. Packaging material
Answer: B
Question 26. Aseptic processing time includes:
A. Only filling time
B. Entire process from preparation to filling
C. Only sterilization steps
D. Only environmental monitoring
Answer: B
Question 27. Filling time should be:
A. Uncontrolled
B. Minimized and validated
C. Based only on equipment speed
D. Increased for efficiency
Answer: B
Question 28. Aseptic operations should be regularly observed by:
A. New trainees
B. Operators only
C. Personnel with specific expertise in aseptic processing
D. External auditors only
Answer: C
Question 29. Observations of aseptic operations should verify:
A. Operator comfort
B. Correct performance and operator behavior
C. Speed of work
D. Lighting levels
Answer: B
Question 30. Inappropriate practices observed during aseptic operations should be:
A. Ignored until the next audit
B. Addressed immediately
C. Added to annual reports only
D. Documented without follow-up
Answer: B