Annual Product Quality review in pharmaceutical industry I APQR in pharmaceutical industry
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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. What if no batches are manufactured in the review period of APQR ?
Q. For how long APQR shall be retained ?
Q. What is CpK value and what is acceptance criteria for CpK value?
Q. What are EMA’s requirements for batch consideration for APQR ?
Q. Explain the key components of an APQR report ?
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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5 окт 2023
