Implementing Risk- and Knowledge Management Tools Into Product- and Process Development According to Quality by Design

By using Quality by Design (QbD) and Process Analytical Technology (PAT) approaches in pharmaceutical development more and even more complex information is generated, which has to be available, managed and shared over the whole development and product lifecycle. Therefore the use of knowledge management tools is becoming an integral part to fulfill the requirements of ICH Q8/9/10. Ontologies as knowledge management tools are already in use in other producing industries such as automotive and aerospace to manage and exchange information and data in a consistent and transparent way between selected business units across the product lifecycle. In this paper the combination of the knowledge management tool ontology with the entire quality risk management process is discussed to implement a knowledge and risk based approach into the pharmaceutical product and process development lifecycle according to ICH principles. In this first step, the ontology is seen as a domain-specific structured knowledge base for 'Failure Mode and Effect Analysis' (FMEA) and 'Cause-and-Effect Diagram' (CED) related concepts and entities. Therefore objects of different domains such as risk analysis process, requirements, organization and others are modeled according to the newly developed 'GxP-OntoV' methodology. This new methodology extends traditional ontology development processes to fulfill the needs of GAMP 5.0 and GxP requirements for computerized systems. An interdisciplinary approach was created, so that the ontology is specified comprehensively from the beginning and can be properly verified and successfully validated. As development environment the open source ontology editor 'Protégé' is used. The open standard 'Web Ontology Language' (OWL) serves as implementation language. Subsequently the ontology is extended by integration of further related concepts and entities e.g. product and process development steps, validation activities. For the presentation the 'GxP-OntoV' methodology as well as the first development results of the 'Quality by Design/Risk Management Ontology' will be discussed in detail.&'