CMC Process Validation Walkthrough

Video

Delivering Data Driven Value

CMC Process Validation Walkthrough

The Pistoia Alliance has completed Phase 1 / Proof of Concept to build a pharmaceutical CMC process ontology based on the ISA88/95 framework to standardize laboratory and plant production process recipes, establish standardized definitions, facilitate digital technology transfers and integration with execution systems to capture structured process data for material lot genealogy tracking, streamlined technology transfers, and advanced process analytics; thereby enhancing efficiency and transparency throughout the pharmaceutical production lifecycle.

In this video, we show how we have imported the developed core CMC process ontology as well as two controlled vocabularies for referring to the different parameter measurements as well as the different recipe steps that make up a manufacturing process to create a knowledge graph to answer our competency and business questions.