Roundtable Discussion – Reviewing Release Criteria for Product Purity to Understand How to Meet Them & Ensure High Purity
- Exploring what the release criteria for product purity is, including identifying acceptable limits for impurities and relevant quality attributes.
- Evaluating how to prove product purity using appropriate analytical techniques and risk-based testing strategies
- Optimizing analytical methods to show product purity in accordance with release criteria, ensuring accuracy, sensitivity, and reproducibility