4.3. Linking QbD to the St. Galler Model of Integrated Management

As already indicated by the supply chain activities and the importance of management commitment to and its support for QbD, QbD is definitely not an isolated approach within R&D. Neither is it limited to interactions between R&D functions and other functional units in a company. QbD is a holistic approach to improve quality based on a change in the philosophy of development, which then has to drive the change in objectives, responsibilities and processes during the development of new drug products and throughout the lifecycle of a drug product.

St. Galler Model of Integrated Management" class="wp-image-10016 size-full" height="507" src="https://sgbs.ch/wp-content/uploads/Figure-6-Linking-the-implementation-of-QbD-in-a-pharmaceutical-company-to-the-St.-Galler-Model-of-Integrated-Management.png" width="623"> Figure 6: Linking the implementation of QbD in a pharmaceutical company to the St. Galler Model of Integrated Management

Figure 6 links the QbD philosophy to the “St. Galler Integrated Management Philosophy”⁵⁶ and depicts where and how the principles of QbD and its systems need to be integrated at the normative, strategic and operational level of a corporation. Furthermore, the model needs to be extended at least for the customer segment of the health authorities and their interdependency in the QbD philosophy, which needs to be established as a minimum at the strategic and operational levels. Other customer segments, such as the health care systems, health care providers and finally the patient himself might also be integrated into this model for a QbD driven business philosophy. Drug products are a rather complicated market due to the interdependency between health care systems for reimbursement, health care providers for execution and patients as the final beneficiaries, and this needs to be reflected also in the management philosophy and even more so in a QbD driven management philosophy.

⁵⁶ Source: Bleicher K.; Das Konzept Integriertes Management; 2011; p 91(author’s own adaptation)