Area Qualification in pharmaceutical industry I 15 Interview questions and answers

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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[@Chikuonline]

Sir what is difference between processing area and quarantine area regarding qualifications

[@PharmGrow]

Processing area is area in which batch processing is carried out like Granulation, compression, coating, formulation, filling etc. in Quarantine area we keep processed or to be processed materials like in-process area, day stock area, cold rooms etc.

[@vinodmetakar6446]

Hu

[@PharmGrow]

Not understood