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

作者：Guebitz Brigitte; Schnedl Hubert; Khinast Johannes G^*

来源：Expert Systems with Applications, 2012, 39(8): 7291-7301.

DOI：10.1016/j.eswa.2012.01.089

• Quality risk management
• Ontology
• GAMP
• Quality by Design
• Knowledge management
• Development approach

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 %26quot;ontology%26quot; is generally defined and described with regard to the knowledge domain of quality risk management. %26lt;br%26gt;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.

• 出版日期2012-6-15