Can you describe your experience with stability testing and shelf-life determination?

Sample interview questions: Can you describe your experience with stability testing and shelf-life determination?

Sample answer:

• Stability Testing:

  • Conducted comprehensive stability studies on various pharmaceutical products, following ICH guidelines and cGMP regulations.
  • Evaluated product characteristics such as appearance, color, odor, pH, assay, degradation products, and other relevant parameters over time under specific storage conditions.
  • Designed and implemented stability protocols, including storage conditions, sampling intervals, and analytical methods.
  • Analyzed stability data using statistical methods to determine shelf life and provide recommendations for storage and handling conditions.

• Shelf-Life Determination:

  • Determined the shelf life of pharmaceutical products through accelerated and real-time stability studies.
  • Developed and validated accelerated stability protocols that accurately predict long-term stability.
  • Extrapolated stability data using Arrhenius plots and kinetic models to estimate shelf life under various storage conditions.
  • Provided stability data and recommendations to support product labeling, storage, and distribution.

• Expertise and Skills:

  • Proficient in various analy… Read full answer

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