No validation is required for characterization. However, you should demonstrate that the analytical method is measuring what it is supposed to do. E.g. if you are using an ELISA supposed to measure and quantitate impurities in a bioprocess and DS, you should demonstrate HCP coverage and dilutional linearity.

Ejvind Mørtz, PhD, Co-Founder & COO of Alphalyse in Denmark, discusses the regulatory expectations for HCP analysis, highlighting the importance of USP <1132.1> to improve MS-based data quality. Don’t miss his presentation and expert insights at the panel discussion.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/

No qualification or validation is required for analytical characterization methods. Having said that, regulatory agencies do expect that analytical characterization is performed using ‘fit-for-purpose’, ‘scientifically sound’ methods. In my experience, this means that several aspects that hold for GMP analytical methods also hold for characterization methods. After all, you do want to generate robust high-quality data consistently. For example, the right controls/standards should be included for SST to ensure good performance of the method across all steps (digestion, LC, MS, data processing, etc.).

Don’t miss Eef Dirksen, Director of Analytical Development and Quality Control at Byondis (Netherlands), who discusses regulatory expectations for HCP analysis and highlights the importance of USP <1132.1> in improving MS-based data quality.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/