Developing Reference Materials for Robust Lot-to-Lot Testing to Achieve Consistency Across Product Release
Time: 1:30 pm
day: Workshop F
Details:
An interactive discussion of challenges and practices to develop reference materials, as to maintain analytical method performance, to evaluate assay/process/facility comparability, and to ensure consistent product quality and efficacy.
Key discussion points:
- Development of reference materials
- Characterization of reference materials
- Applications of reference materials in lot release of drug product intermediate and drug product
