This seminar provides an in-depth overview of modern pharmaceutical quality assurance with a focus on elemental impurities, water quality, and advanced analytical technologies. It covers regulatory requirements per USP <232>, <233>, and ICH Q3D, emphasizing the use of Inductively Coupled Plasma (ICP) for precise and robust elemental impurity testing. Also highlights Total Organic Carbon (TOC) analysis as a critical tool for monitoring water quality, cleaning validation, and plastic packaging safety in accordance with USP 661.1 and 661.2. Furthermore, the role of Raman spectroscopy as a real-time, non-destructive Process Analytical Technology (PAT) is explored, demonstrating its benefits in improving process control, reducing batch failures, and enhancing product release efficiency. The integration of single-use technologies and water quality strategies supports agile, contamination-free manufacturing. Together, these approaches illustrate a comprehensive, innovation-driven framework for ensuring product safety, regulatory compliance, and operational excellence in pharmaceutical production.

To present an integrated approach to pharmaceutical quality assurance by exploring innovative technologies such as Raman spectroscopy, TOC analysis, and elemental impurity testing, with a focus on enhancing process control, regulatory compliance, and manufacturing efficiency.

elemental impurity, water quality, advanced analytical technologies

online registration @ http://tipa.or.th/tipa/register/