Conceptual Model for Outsourcing Process in Pharmaceutical Supply Chain

Abstract:

Pharmaceutical companies are regularly being challenged to meet the rising standards of quality, so as to comply with rigorous regulatory requirements. At the same time, the global pharmaceutical market has seen significant changes, forcing pharmaceutical companies to focus more than ever before on customer needs and their own internal efficiencies in order to continue to compete effectively on a local and global arena. Outsourcing services to a third party is a commonly accepted approach to reduce costs and to provide sites of excellence (manufacturing, distribution, research and development, analysis and testing, marketing), but it also holds many hidden risks. The winning formula of outsourcing processes is developing and sustaining a reliable Quality Management System, capable to control efficacy and efficiency of outsourced activities. In this article the conceptual model of outsourcing process has been proposed under the frame of PDCA cycle (Plan, Do, Check, Act). Proposed model has been applied in outsourcing process of transport of medicines, as a case study. Furthermore, this case study has been implemented in the curriculum of postgraduate education in Pharmaceutical management in Faculty of pharmacy on University of Belgrade, as a practical course for understanding the complexity of outsourcing process in pharmaceutical supply chain.

Keywords: Outsourcing, Pharmaceutical supply chain, Quality management