Finishing of Sterile Products WHO GMP
Questions 1. Containers should be closed by:
A. Random methods
B. Appropriately validated methods
C. Visual inspection only
D. Manual sealing without validation
Answer: B
Questions 2. Containers closed by fusion, such as glass or plastic ampoules, should be:
A. Tested in 10% of units
B. Subject to 100% integrity testing
C. Not tested if visually intact
D. Tested only once per batch
Answer: B
Questions 3. Samples of other containers should be checked:
A. For color only
B. According to appropriate integrity procedures
C. Only if the batch fails
D. Randomly without documentation
Answer: B
Questions 4. The container closure system for aseptically filled vials is fully integral:
A. After stopper insertion
B. After aluminum cap has been crimped
C. Before crimping
D. After visual inspection only
Answer: B
Questions 5. Crimping of vial caps should be performed:
A. As soon as possible after stopper insertion
B. At the end of the day
C. Only after visual inspection
D. After storage
Answer: A
Questions 6. Equipment used to crimp vial caps should be located:
A. In the same area as stopper insertion
B. At a separate station with adequate air extraction
C. Anywhere in the cleanroom
D. Outside the cleanroom without air control
Answer: B
Questions 7. Vial capping can be undertaken:
A. Only as an aseptic process
B. As an aseptic process or a clean process outside the aseptic core
C. Only after terminal sterilization
D. Without concern for Grade A conditions
Answer: B
Questions 8. Where capping is done outside the aseptic core, vials should be protected by:
A. Grade B air only
B. Grade A conditions until leaving the aseptic area
C. No air control
D. Visual barriers only
Answer: B
Questions 9. Vials with missing or displaced stoppers should be:
A. Repaired manually
B. Rejected prior to capping
C. Capped anyway
D. Tested only visually
Answer: B
Questions 10. Human intervention at the capping station should:
A. Be unrestricted
B. Use technology to prevent direct contact and minimize contamination
C. Only require gloves
D. Be allowed freely if the operator is trained
Answer: B
Questions 11. Restricted access barriers and isolators:
A. Increase contamination risk
B. Minimize direct human interventions and assure required conditions
C. Are unnecessary in modern cleanrooms
D. Only protect the operators
Answer: B
Questions 12. Containers sealed under vacuum should be tested:
A. Immediately after sealing only
B. After an appropriate predetermined period
C. Only if leakage is suspected
D. Only visually
Answer: B
Questions 13. Filled containers of parenteral products should be inspected:
A. Randomly for color
B. Individually for extraneous contamination or other defects
C. By automated machines only
D. Only if the batch fails chemical testing
Answer: B
Questions 14. Visual inspection should be done under:
A. Any available light
B. Suitable and controlled conditions of illumination and background
C. Dim light to avoid glare
D. Normal room lighting without control
Answer: B
Questions 15. Operators doing inspection should:
A. Work continuously without breaks
B. Pass regular eyesight checks and be allowed frequent breaks
C. Not use corrective lenses
D. Only rely on equipment for inspection
Answer: B
Reference : WHO TRS961 annex 6 good manufacturing practices for sterile pharmaceutical products