Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities. Issues related to process flow, material flow, and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer. Bio-safety levels. Developing effective written procedures, so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do. Levels I, II, and III policies. Clinical phases I, II, III and their effect on plant design. Defending products against contamination. Building quality into products.