Annual Product Quality review in pharmaceutical industry I APQR | interview questions and answers
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this video based on interview questions and answers regarding annual product review called APQR.
interview question and answer
APQR
annual product review
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Questions covered:
Q. Q. What is APQR, and why is it important in the pharmaceutical industry?
Q. Which points are commonly included in the APQR summary report ?
Q. Who shall prepare APQR ?
Q. How do you handle deviations and out-of-specification results in APQR?
Q. Why stability studies are important for APQR ?
Q.: What is importance of trending analysis in APQR ?
Q. How do you ensure that APQR recommendations are effectively implemented?
Q. What software tools or systems we can use for APQR data management and analysis ?
Q. What should be the frequency for preparation of APQR ?
Q. For how long APQR shall be retained ?
Q. What is CpK value and what is acceptance criteria for CpK value?
Q. Whether we can group APQR for different product type e.g. solid dosage forms, liquid dosage forms, sterile products etc ?
Q. Which findings from APQR shall be reported to FDA ?
Q. Which guidelines are referred for APQR in pharmaceutical industry ?
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