We’re pleased to announce that we will be presenting at the Pharma ED Extractables & Leachables West 2025 summit in La Jolla, CA this November 4-5 at the Sheraton La Jolla.
Summit focus: Quality, Safety, Biocompatibility & Regulatory Compliance for Drugs, Biologics, & Med Devices
Join our presentation!
Speaker: Philippe Verlinde, PhD, Senior Technical Advisor Nelson Labs
When: Wednesday November 5, 8:15am to 8:55am
Title: The Use and Value of FDA’s CLAP-list to Support Scientific Quality in Extractable Testing
Abstract: The “Chemical List of Analytical Performance” (CLAP) published by the FDA (CDRH), represents an attempt to significantly improve and harmonize chemical analyses and Non-Target Analytical Methods (NTA-Methods) that are used for biocompatibility assessment of medical devices. These methods inherently come with a high level of variance and uncertainty and henceforth the CLAP can be considered a large step forward to address these inter- and intra-lab variability issues. Although the list could be further expanded, it could set the basis for:
- Optimizing analytical methodologies to minimize gaps and addressing the uncertainty in detectability of a relevant set of compounds.
- Understanding variability of responses per technique.
- Providing the basis to calculate Uncertainty Factors (UF) based on a reference set of compounds.
- Calculating the coverage for a methodology, using the derived UF.
- Providing the basis of a new way of generating Quantitative data: the RRF-approach.
- Minimizing inter-lab variability in Chemical Characterization results.
In this presentation we will show how a lab could make use of this CLAP list and what kind of conclusions can be drawn with respect to the above to support a higher level of scientific quality in extractable testing.
For more information on the conference, please click here
