Pharmaceutical CMC Process Ontology

Our project aims to develop a pharmaceutical (CMC) process ontology, based on the ISA88/95 framework. This ontology will serve to standardize laboratory and plant production process recipes, and in turn, establish standardized definitions. It will also facilitate digital technology transfers, and integrate with execution systems to capture structured process data for material lot genealogy tracking. This will lead to streamlined technology transfers, advanced process analytics, and ultimately, enhance efficiency and transparency throughout the pharmaceutical production lifecycle.