#1. What is the main purpose of Design Qualification (DQ) in a pharmaceutical validation lifecycle?
#2. You’re reviewing the design documents of a new lyophilizer. The chamber insulation material is unspecified. What should happen during DQ?
#3. Which of the following is NOT a primary component of a typical Design Qualification package?
#4. Which of the following actions are appropriate during Design Qualification?
#5. If URS requires the system to operate at 4°C, and the design proposes 8°C, but the vendor claims “it works for others,” what’s the best DQ decision?
#6. Think of Design Qualification as:
#7. During DQ of a computerized blending system, which of the following GMP concerns should be evaluated?
#8. Which validation step directly depends on the quality and completeness of Design Qualification?
#9. Where does Design Qualification (DQ) typically fall in the equipment validation timeline?
#10. Which of the following statements is a red flag during a Design Qualification review?
#11. If designing a pharma-grade mixer is like building a Lego model, what part of the process does DQ represent?
#12. DQ ensures that the ___ meets the ___ before physical implementation begins.
#13. Which document is most critical for initiating Design Qualification?
#14. Which of the following does NOT belong in the DQ phase?
#15. While reviewing DQ documents, you notice the piping layout lacks drain points. What should the team do?
#16. During DQ of a computerized weighing system, which of the following should be prioritized?
#17. You’re part of a team purchasing a sterilizer. What’s your next step after DQ is complete?
#18. A company installs a machine without performing DQ. Later, it fails to meet contamination control standards. What is the likely cause?
#19. A team completed Installation Qualification (IQ), but later realized the system doesn’t meet URS. What was most likely missed?
#20. Which of the following statements about DQ is most accurate?
#21. “If Design Qualification is not properly executed, then…”
