HVAC Qualification / HVAC Validation in pharmaceutical industry I 30 Interview questions and answers
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Questions covered:
1. What is HVAC qualification in the pharmaceutical industry?
2. Why is HVAC qualification important in the pharmaceutical industry?
3. What are the different stages of HVAC qualification?
4. Who is responsible for conducting HVAC qualification?
5. What is covered in the design qualification (DQ) phase?
6. What does the installation qualification (IQ) phase involve?
7. What is tested during the operational qualification (OQ) phase?
8. What does the performance qualification (PQ) phase evaluate?
9. How often should HVAC qualification be conducted?
10. What is the purpose of a risk assessment in HVAC qualification?
11. How can a pharmaceutical company ensure compliance during HVAC qualification?
12. What is the impact of HVAC system failures on pharmaceutical production?
13. Can HVAC qualification be performed in a facility already in operation?
14. How can continuous monitoring contribute to HVAC qualification?
15. How does HVAC qualification align with regulatory requirements?
16. Which are the five commonly performed tests during HVAC qualification ?
17. What are the typical acceptance criteria for HVAC qualification tests?
18. How does HVAC qualification impact energy efficiency and sustainability?
19. How can deviations and non-conformities identified during HVAC qualification shall be addressed?
20. What are the major components of HVAC system in pharmaceutical industry ?
21. What is requirement for Airborne particulate in Grade A, B, C and D area?
22. Can HVAC qualification be extended to the cleanroom environment?
23. How does HVAC qualification support regulatory inspections and audits?
24. How does HVAC qualification address the risk of cross-contamination in pharmaceutical manufacturing?
25. Can HVAC qualification impact the shelf life and stability of pharmaceutical products?
26. What are the key documentation requirements for HVAC qualification?
27. How does HVAC qualification support the validation of pharmaceutical manufacturing processes?
28. Why 0.2 micron filter is used in HVAC system in the pharmaceutical industry ?
29. Can HVAC qualification impact employee safety and comfort?
30. Which guidelines are commonly referred for HVAC qualification ?
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