The successful design and realization of an FDA-validatable facility does not happen by chance. Early coordination and communication among all parties involved is essential, from process design and scale-up through cGMP layout, FDA pre-construction design review, commissioning, validation, and on-site inspection by regulatory authorities. A complete "Basis of Design" document is necessary to optimize the utilization of scarce resources. Time spent in design optimization in the front-end, well in advance of the "bricks and mortar" stage, will be saved many times over.