Terminally Sterilized Products EUGMP- Annex-1
Question 1. Preparation of components and materials for terminally sterilized products should be performed in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Question 2. The purpose of using at least a Grade D room for preparation is to limit:
A. Temperature deviation
B. Microbial, endotoxin/pyrogen, and particle contamination
C. Operator fatigue
D. Equipment breakdown
Answer: B
Question 3. If a product has a high or unusual risk of microbial contamination, preparation should be done in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 4. Preparation of ointments, creams, suspensions, and emulsions for terminal sterilisation should occur in:
A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: B
Question 5. Cleaning of primary packaging containers and components must use processes that are:
A. Convenient
B. Validated
C. Automated
D. Performed in Grade A only
Answer: B
Question 6. Validated cleaning processes ensure control of:
A. Light exposure
B. Particle, endotoxin/pyrogen, and bioburden contamination
C. Storage temperature
D. Energy consumption
Answer: B
Question 7. Filling of products for terminal sterilization should be carried out in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 8. When a product is unusually at risk during filling, the required filling grade is:
A. Grade D
B. Grade C
C. Grade A
D. Grade B
Answer: C
Question 9. For unusually high environmental contamination risks, filling should occur in Grade A with:
A. Grade A background
B. Grade B background
C. Grade C background
D. No background is required
Answer: C
Question 10. An example of an unusual contamination risk during filling is:
A. Use of closed sterile tubing
B. Slow filling operation
C. Low viscosity liquid
D. Use of small narrow-necked containers
Answer: B
Question 11. Wide-necked containers pose:
A. No additional risk
B. A reduced need for cleanroom controls
C. An unusual risk of contamination
D. Only a physical risk, not microbial
Answer: C
Question 12. Processing of bulk solution should include:
A. UV light exposure
B. Filtration with a microorganism-retaining filter
C. High-speed blending
D. Freeze drying
Answer: B
Question 13. Filtration before filling helps reduce:
A. Colour variation
B. Bioburden and particles
C. Labeling errors
D. Container breakage
Answer: B
Question 14. There should be a maximum permissible time between:
A. Component cleaning and packaging
B. Preparation and filling
C. Equipment setup and qualification
D. Staff training and certification
Answer: B
Question 15. Which grade is used for filling of products when unusually at risk?
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: A
Question 16. Grade C operations include:
A. Filling of high-risk products
B. Preparation of solutions when unusually at risk
C. Cleaning of components
D. Assembly of sterile connectors
Answer: B
Question 17. Grade C is also used for:
A. Filling of products
B. Labelling of finished goods
C. Final packaging
D. Equipment disassembly
Answer: A
Question 18. Grade D operations include:
A. Preparation of solutions
B. Filling of products
C. Labelling
D. Sterile filtration
Answer: A
Question 19. Preparation of components for subsequent filling should be carried out in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: D
Question 20. According to the text, guidance for terminally sterilized veterinary medicinal products is found in:
A. Annex 1
B. Annex 2
C. Annex 3
D. Annex 4
Answer: D
Question 21. A product that must be held for long periods before filling presents:
A. No contamination risk
B. A high or unusual risk
C. A packaging risk only
D. A labeling risk
Answer: B
Question 22. A product that supports microbial growth should be prepared in at least:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 23. Why must containers not remain exposed for long periods before closing?
A. They may cool too fast
B. They increase contamination risk
C. They may lose label adhesion
D. They may become discoloured
Answer: B
Question 24. The CCS (Contamination Control Strategy) is used to:
A. Determine staff assignments
B. Identify unusual contamination risks
C. Schedule maintenance
D. Conduct validation
Answer: B
Question 25. Microorganism-retaining filters help ensure the solution is:
A. Sterile
B. Low in nutritional value
C. Free of preservatives
D. Colourless
Answer: A
Question 26. Preparation of solutions when not unusually at risk is performed in:
A. Grade A
B. Grade C
C. Grade D
D. Grade B
Answer: C
Question 27. Preparation of solutions when unusually at risk is performed in:
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: C
Question 28. The grade assigned for component preparation before filling is:
A. Grade A
B. Grade C
C. Grade D
D. Grade B
Answer: C
Question 29. Which grade is not mentioned as necessary for terminally sterilized product preparation or filling?
A. Grade A
B. Grade B
C. Grade C
D. Grade D
Answer: B
Question 30. Terminal sterilization occurs:
A. Before solution preparation
B. After filling and sealing
C. Before filtration
D. In place of component cleaning
Answer: B