CMC Process Validation Walkthrough Ontology Video


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.

If you want to know more and get involved in the project's second phase, please get in touch with birthe.nielsen@pistoiaalloance.org

To be involved at the beginning of any of the Pistoia Alliance projects enables, you, the sponsor, to access the following benefits. 

  • Steering committee status - you help us guide the project in a way that it can benefit the industry
  • Expand your network and knowledge of the subject matter 
  • Encourage conversions and innovation within your company and industry

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