Particle Sizing and the PAT initiative

摘要

Interest in the role of on-line analytical procedures is growing as the US Food and Drug Administration (FDA) moves to implement its cGMPs for the 21st Century initiative. It is now well established that on-line particle size monitoring can optimize the efficiency of a manufacturing process, simplify production operations and improve the quality of the end product. This has become especially important in the pharmaceutical industry where the FDA has set out a new initiative concerning current good manufacturing practices (cGMP) and the introduction of process analytical technologies (PAT) for continuous quality assurance. PAT is the pharmaceutical industry's drive to provide real-time information to characterize and control process variation and manufacturing capability [1]. Taking the Malvern Insitec system as a model, this article examines the role of on-line particle size analysis in enabling manufacturing companies to implement PAT in accordance with the FDA initiative.