Sterile Product Finishing EUGMP- Annex-1
Questions 1. Open primary packaging containers must be maintained under which conditions?
A. Grade B
B. Grade C
C. Grade A
D. Grade D
Answer: C
Questions 2. Final containers should be closed using:
A. Any available method
B. Manually approved methods
C. Appropriately validated methods
D. Vendor-recommended methods only
Answer: C
Questions 3. Containers closed by fusion include:
A. Glass vials with rubber stoppers
B. Blow-Fill-Seal (BFS), FFS, ampoules, SVP/LVP bags
C. Prefilled syringes only
D. Blister packs
Answer: B
Questions 4. For glass ampoules and small fused containers (≤100 ml), integrity testing should be:
A. Performed on 10% samples
B. Performed on 25% of the batch
C. 100% integrity tested
D. Not required
Answer: C
Questions 5. Visual inspection alone is considered:
A. Fully acceptable for integrity testing
B. Partially acceptable
C. Not an acceptable integrity test method
D. Mandatory for integrity
Answer: C
Questions 6. For containers >100 ml closed by fusion, reduced sampling is acceptable when:
A. The batch is small
B. No defects are visible
C. Scientifically justified with consistent process control
D. Inspector authorizes it
Answer: C
Questions 7. Integrity testing for non-fusion closure systems should be:
A. Occasional
B. Based on validated methods and sampling plans
C. Only visual
D. Not required
Answer: B
Questions 8. Sampling size for non-fusion systems should be based on:
A. Customer demand
B. Supplier management and process knowledge
C. Random selection only
D. Cost of testing
Answer: B
Questions 9. Containers sealed under vacuum should be tested for maintenance of vacuum:
A. Immediately after sealing only
B. Only during release
C. After a pre-determined period and during shelf life
D. Only before shipment
Answer: C
Questions 10. Container closure integrity validation must consider:
A. Retail pricing
B. Transport conditions like decompression or extreme temperatures
C. Batch size
D. Labeling artwork
Answer: B
Questions 11. Crimping equipment that generates non-viable particles should be located:
A. In the aseptic filling zone
B. In a physically separate station with air extraction
C. Inside a warehouse
D. In a grade A cleanroom
Answer: B
Questions 12. When vial capping is done outside aseptic area as a clean process, vials must be protected by:
A. Grade C airflow
B. Grade B airflow
C. Grade A airflow up to cap crimping
D. No special airflow
Answer: C
Questions 13. Background environment supporting grade A air supply during capping should be at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Questions 14. Manual capping should be performed under:
A. Grade C
B. Grade D
C. Grade A in an isolator or Grade A with Grade B background
D. Grade E
Answer: C
Questions 15. For clean-process capping, vials with missing or displaced stoppers should be:
A. Reprocessed
B. Re-stoppered
C. Rejected before capping
D. Sent to QC
Answer: C
Questions 16. Detection of stopper height should be:
A. Manual only
B. Automated and appropriately qualified
C. Done randomly
D. Optional
Answer: B
Questions 17. When human intervention occurs at capping station, contamination should be minimized using:
A. Frequent cleaning
B. RABS or isolators
C. Increased lighting
D. Longer gloves
Answer: B
Questions 18. All filled parenteral containers must be inspected:
A. Randomly
B. Only visually
C. Individually for contamination or defects
D. Only if defects are suspected
Answer: C
Questions 19. Defect classification should be based on:
A. Production cost
B. Operator experience
C. Risk and historical knowledge
D. Container design
Answer: C
Questions 20. A defect library is required for:
A. Supplier evaluation
B. Training production and QA personnel
C. Marketing teams
D. Transport teams
Answer: B
Questions 21. Any critical defect found after initial inspection should:
A. Be ignored
B. Trigger re-labeling
C. Trigger an investigation
D. Be discarded silently
Answer: C
Questions 22. Manual inspection must occur under:
A. Low lighting
B. Controlled illumination & background
C. Outdoor light
D. Grade D airflow
Answer: B
Questions 23. Operators performing manual inspection must be qualified:
A. Every 5 years
B. Only once
C. At least annually
D. Only during onboarding
Answer: C
Questions 24. Manual inspection qualification must include:
A. Only written test
B. Vision testing and use of defect library samples
C. Physical fitness exam
D. Interview with QA
Answer: B
Questions 25. Operator fatigue during inspection should be addressed by:
A. Increasing line speed
B. Allowing frequent breaks
C. Reducing lighting
D. Increasing workload
Answer: B
Questions 26. Automated inspection methods must be:
A. Faster than manual inspection
B. Validated to detect known defects
C. Used only for large batches
D. Free from human monitoring
Answer: B
Questions 27. Automated inspection equipment performance should be challenged:
A. Only during qualification
B. Only at year-end
C. Before start-up and at regular intervals
D. Never
Answer: C
Questions 28. Defect numbers and types must be:
A. Reported only to management
B. Erased after review
C. Trended based on statistical principles
D. Ignored unless critical
Answer: C
Questions 29. Investigation of adverse trends must include:
A. Production yield data
B. Impact on market products
C. Marketing feedback
D. Utilities performance
Answer: B
Questions 30. Containers with unusual defect levels must be:
A. Automatically released
B. Moved to warehouse
C. Investigated
D. Repacked
Answer: C