Business Process Model of Continuous Improvement in Pharmaceutical Manufacturing

To further raise quality and cost-effectiveness in the pharmaceutical industry, we have developed and operationalized a business process model of continuous improvement for production processes. All required activities, information and tools for process improvement were defined using the activity-modeling method termed Integrated Definition type 0 ( IDEF0). Elements for considering impacts of process changes on product quality and patient safety, which are vital in the pharmaceutical industry, were also incorporated into the model. In addition, the so-called RACI method was applied to classify the roles and responsibilities of all involved stakeholders, including management, staff, quality assurance and engineering, as Responsible, Accountable, Inform and Consult (RACI). THis complementary combination of RACI and IDEF0 enabled the definition of the roles and responsibilities of multiple stakeholders that participate in an activity. The business process model was developed based on the actual activities of continuous improvement in a Parenterals production facility of a Swiss pharmaceutical company, Roche. As a case study, a project on reducing product losses in the Parenterals production process is presented along with the model, in order to demonstrate its effectiveness.