February 2025

Many developments in silica particles used in liquid chromatography (LC) have been well documented over the years. The move from irregular silica to spherical silica, the decrease in particle size from >5µm particle in high performance liquid chromatography (HPLC) to sub-2-µm particle size in ultrahigh-pressure LC (UHPLC), the improved silica purity of type B silica…

BackgroundIn 2002, US-FDA launched an initiative, ‘‘Pharmaceutical CGMPs for the 21st Century—A Risk-Based Approach,’’ to enhance and modernize the regulation of pharmaceutical manufacturing and product quality.1 One objective, among others, was to facilitate the implementation of a modern, Risk-based Pharmaceutical Quality Assessment system. The desired state has been described as a maximally efficient, agile, flexible…