The regulatory focus of facilities that manufacture therapeutic products for humans is centered on a product-process-facility attribute driven methodology where risk identification and mitigation are critical quality attributes. Under this methodology, the manufacturing process and the product requirements, not the building, become not only the main drivers for CD efforts, but must also provide a clear approach and understanding of how the building elements must be defined and operated in order to ensure patient safety in the manufacture of the product. This requires an enterprise approach to facility design focusing on: Process-driven understanding around operational analysis Regulatory philosophy Business drivers Management needs Integrated hand-off to detailed design activities