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

  • Authors:
  • Brigitte Guebitz;Hubert Schnedl;Johannes G. Khinast

  • Affiliations:
  • Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 21a, A-8010 Graz, Austria and VTU Engineering GmbH, Parkring 18, A-8074 Grambach, Austria;The Lifecycle Intelligence Group GmbH, Sackstrasse 26, A-8010 Graz, Austria;Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 21a, A-8010 Graz, Austria and Institute for Process and Particle Engineering, Graz University of Technology, Inffeldgasse 21a, A-8010 ...

  • Venue:
  • Expert Systems with Applications: An International Journal
  • Year:
  • 2012

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Abstract

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.