Area Qualification in pharmaceutical industry I 15 Interview questions and answers
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Questions covered:
Q. What is Area Qualification in Pharmaceutical Industry?
Q. How often should area qualification be performed?
Q. What are the key objectives of area qualification?
Q. Which are the important area qualification tests ?
Q. Explain the concept of "worst-case scenario" in area qualification?
Q. How do you perform air quality monitoring in a cleanroom as part of area qualification?
Q. What is a smoke study, and how is it conducted for area qualification?
Q. How can you ensure that a qualified area remains in a state of control after initial qualification?
Q. How do you perform a temperature mapping study for storage areas during area qualification?
Q. Explain the concept of “Retrospective validation" in area qualification?
Q. What are the temperature and relative humidity requirements in pharmaceutical area ?
Q. What is the common differential pressure between the two areas ?
Q. Which are the five stages of area Qualification ?
Q. Why minimum consecutive three days Monitoring done in area Qualification ?
Q. Which guidelines are commonly referred for Area Qualification in pharmaceutical industry ?
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