23 European Symposium on Computer Aided Process Engineering

This study presents a business model of continuous improvement in pharmaceutical production processes. The model covers the lifecycle of an improvement, i.e. opportunity identification, project execution and change implementation, with considering various pharma-specific constraints such as GMP (Good Manufacturing Practice). The model is described as so-called an activity model using IDEF0 (Integrated DEFinition type 0) in order to define activities and sub-activities in a clear and consistent manner. A roll-defining model termed RACI (responsible, accountable, consulted and informed) is uniquely combined with the IDEF0 model, for characterizing roles of various stakeholders in each improvement step. The model was developed and applied in a new sterile drug product manufacturing facility of Roche in Kaiseraugst, Switzerland. In this start-up facility, a case study was performed for reducing losses of valuable biologics drug products with a continuous and organization-wide effort.