Stability Study Design & Shelf-Life Evaluation – Corporate Training

Description

Stability Study Design & Shelf-Life Evaluation – Corporate Training

This training program equips pharmaceutical professionals with the knowledge and practical skills required to design, execute, and interpret stability studies in line with global regulatory expectations.

Key Learning Areas:

• Stability Study Design & Protocol Development
  Designing stability protocols in accordance with ICH guidelines, including appropriate storage conditions (temperature, humidity, light exposure) and selection of relevant time points.
• Degradation Pathways & Stability-Indicating Factors
  Identifying potential degradation pathways, critical stability parameters, and monitoring both active pharmaceutical ingredients (API) and impurities or degradation products.
• Shelf-Life Determination & Data Evaluation
  Establishing product shelf life based on real-time stability data, with scientifically justified extrapolation using statistical tools and consideration of packaging and storage conditions.
• Analytical Method Suitability
  Ensuring the use of validated, stability-indicating analytical methods capable of detecting degradation products and potency changes accurately.
• Stability Monitoring & Lifecycle Management
  Conducting real-time and accelerated stability studies, managing post-approval stability commitments, and performing re-assessment following changes in formulation, manufacturing process, packaging, or storage conditions.

  Note: A detailed training module and customised curriculum can be provided upon request.