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.