Stability studies / Stability testing in pharmaceutical industry I Interview questions and answers

Stability studies / Stability testing in pharmaceutical industry I 30 Interview questions and answers
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Questions covered:
Q. What is the purpose of stability studies in the pharmaceutical industry?
Q. What are the different stability zones for drug products?
Q. How are stability testing time points determined?
Q. What are the recommended storage conditions for stability studies?
Q. What are the key parameters monitored during stability studies?
Q. What is the difference between real-time and accelerated stability studies?
Q. What is the significance of the Arrhenius equation in stability studies?
Q. How do you determine the shelf-life of a drug product from stability data?
Q. What is the purpose of stress testing in stability studies?
Q. How are stability data used in the drug approval process?
Q. What is the role of stability indicating methods in stability studies?
Q. What are the acceptance criteria for stability studies?
Q. How do you handle photostability testing in stability studies?
Q. What is the impact of temperature excursions on stability studies?
Q. How do you establish a retest period for drug substances in stability studies?
Q. What is the role of statistical analysis in stability studies?
Q. How do stability studies account for container closure systems?
Q. What are the requirements for stability data storage and recordkeeping?
Q. How are stability studies impacted by scale-up and post-approval changes?
Q. What is the purpose of the Bracketing and Matrixing design in stability studies?
Q. How do you determine the frequency of stability testing for a drug product?
Q. What are the implications of stability data exception or deviation in stability studies?
Q. How is the photostability of a drug product assessed in stability studies?
Q. What is the role of stability studies in post-marketing surveillance??
Q. What are the four major product degradation types ?
Q. What are the implications of stability data non-compliance during regulatory submissions?
Q. How do you establish a dissolution specification in stability studies?
Q. What is the role of stability studies in post-approval change management?
Q. How are stability studies affected by variations in regional climatic conditions?
Q. Which Guideline are commonly referred for stability studies in pharmaceutical industry ?

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