A risk management ontology for Quality-by-Design based on a new development approach according GAMP 5.0

A new approach to the development of a risk management ontology is presented. This method meets the requirements of a pharmaceutical Quality by Design approach, good manufacturing practice and good automated manufacturing practice. The need for a risk management ontology for a pharmaceutical environment is demonstrated, and the term ‘‘ontology’’ is generally defined and described with regard to the knowledge domain of quality risk management. To fulfill software development requirements defined by good manufacturing practice regulations and good automated manufacturing practice 5.0 for the novel development approach, we used a V-model as a process model, which is discussed in detail. The development steps for the new risk management ontology, such as requirement specification, conceptualization, formalization, implementation and validation approach, are elaborated. 2012 Elsevier Ltd. All rights reserved.