Data integrity problems in pharmaceutical quality control laboratories are driving more regulatory action than ever before. It is obvious that something has changed to drive all this activity. There is plenty of information available, but much of it seems to confuse or frustrate rather than clarify or help. In this summary, we will provide clarity, dispelling confusion by looking at the facts, based on a study of available resources and direct interactions with FDA staff and their consultants. You’ll learn from Loren Smith, Agilent’s software compliance expert and a UC Berkeley instructor with 25 years of regulated software experience, how to put the current enforcement environment in historical context, and to apply critical thinking skills to what you hear or read regarding data integrity. You’ll also learn how to evaluate your current laboratory software and associated processes against these new expectations, as well as how vendors are redesigning laboratory software to help you respond to these new realities.
High-Throughput Analysis of Volatile Compounds in Air, Water, and Soil Using SIFT-MS (Apr 2024)
March 27th 2024This study demonstrates high-throughput analysis of BTEX compounds from several matrices (air, water and soil). Detection limits in the single-digit part-per-billion concentration range (by volume) are readily achievable within seconds using SIFT-MS, because sample analysis is achieved without chromatography, pre-concentration, or drying. We also present a calibration approach that enables speciation of ethylbenzene from the xylenes in real time.
Adoption of SIFT-MS for VOC Pollution Monitoring in South Korea
March 27th 2024This publication reviews VOC pollutant monitoring applications of SIFT-MS in South Korea. SIFT-MS has been applied to emission source characterization, fenceline monitoring, ambient monitoring, pollution mapping, and incident response (including the use of drone-based sampling) for hazardous air pollutants (HAPs), odor nuisance species, and compounds that have high ozone formation potential (OFP) and/or contribute to secondary aerosol (SOA) formation.
Application Compendium: Alternative Proteins Testing
March 21st 2024Agilent workflow solutions, designed for the food and beverages industry, serve as a comprehensive resource for testing alternative proteins. This compendium provides 15 applications across various domains, such as taste and flavor, nutrition, food quality, and food safety leveraging advanced analytical techniques like ICP-MS, LC/MS, GC/MS, and HPLC.