Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
Ravi Kiran Kaja, PhD, senior principal Scientist at the United States Pharmacopeia (USP), spoke with PharmTech ahead of
Kaja explains that system suitability standards are a quality check on the analytical system before a laboratory starts an E&L study. E&L testing looks for trace-level unknown compounds across a broad chemical space using techniques such as gas chromatography-mass spectroscopy (GC-MS) and liquid chromatography-MS. Because of this, small differences in instrument performance, sensitivity, or chromatographic separation can significantly change results. Until now there has been no standardized way to evaluate system performance in E&L screening, so 2 laboratories analyzing the same sample could reach different conclusions. A common framework for checking performance makes the data more trustworthy and easier to compare between laboratories. It also strengthens the patient safety decisions that rely on those data. As Kaja puts it, data cannot be compared until the quality of the measurement system producing them is standardized.
To close this gap, USP launched a global initiative with industry, regulators, manufacturers, and contract laboratories. The effort began with stakeholder engagement and scientific publications and grew into a large international round-robin study across multiple laboratories and analytical platforms. From those results, USP developed and refined 4 system suitability mixtures covering the major techniques used in organic E&L screening. Kaja stresses that the initiative is built on real-world laboratory experience and broad participation rather than on a single laboratory’s approach. Next, USP plans to encourage wider adoption, gather more implementation data, and fold what it learns into the modernization of its E&L standards framework. The aim is to build confidence in the data those standards produce.
Dr. Kaja will be moderating the presentation, Seeing Inside the Dose: Predictive Drug Development with Microstructure Intelligence, will be held on Wednesday, October 28 at AAPS PharmSci 360.
More about this keynote session:
AAPS PharmSci 360: Microstructure Intelligence in Predictive Drug Development, Part 1
AAPS PharmSci 360: Microstructure Intelligence in Predictive Drug Development, Part 2
