Stability Studies of Pharmaceutical Products

About the Course

This training module on Stability Studies in Pharmaceuticals provides a concise yet thorough overview of stability principles, regulatory expectations, and execution across the product lifecycle. It covers study types, protocol design, testing, documentation, and key Schedule M requirements for various product categories. The module emphasizes the importance of stability in ensuring product quality and regulatory compliance

• Stability Studies
  • What are stability studies and why are they essential?
  • Stability of a biologic
  • Regulatory guidelines on stability studies
  • Types of stability studies
  • Product life cycle
  • Development & Clinical Studies
  • Studies for Market Authorization
  • Post Approval Studies
• Steps in a Stability Study
  • Protocol design and content
  • Protocol approval and batch selection
  • Routine Stability
  • Sampling and testing
  • Stability test design, testing frequency & replicates
  • Test and specifications & key stability testing parameters
  • Stability indicating tests: Stability and storage conditions
  • Evaluation criteria: Monitoring and reporting
  • Documentation and record keeping
  • OOS, outliers, CAPA, Process Excursions
  • Premature Termination and final closure
• Schedule M Requirements for Stability
  • Warning letters
  • Objective of stability studies for different products
  • Phytopharmaceutical products
  • Active Pharmaceutical Ingredients
  • Finished Pharmaceutical Products
  • Radiopharmaceuticals & Packaging Materials
  • Stability Monitoring Protocols
  • Regulatory compliance

Summary and Conclusion: Importance of stability & regulatory compliance

Final Evaluation: 3 attempts to achieve the passing score in the evaluation.