CMC-Manufacturing Process-O

Pharmaceutical CMC Process Ontology

The Pharmaceutical CMC (Chemistry, Manufacturing, and Controls) Process Ontology standardizes and digitizes laboratory and plant production process recipes. 

It is based on

  • ISA88: Batch control
  • ISA95: Enterprise-Control System Integration

Source

https://www.pistoiaalliance.org/projects/pharmaceutical-cmc-process-ontology/

Problem statement

The lack of standards (concepts, relationships and their respective definitions) prevents to have an end-to-end understanding of the CMC/drug manufacturing process.

As a result, it is labour-intensive to identify, track, reconcile  and map entities along the manufacturing process.

Objective

Standardized (for humans and machines) the concepts and their  relationships characterizing the process and recipees to manufacture drugs:

    • small chemical molecules
    • large biological molecules

The aim being to facilitate data exchange between systems and enable tracking of  entities (raw, transformed, bulk, final, packaged … material, ) end-to-end of the manufactuering process.