This chapter begins with an overview over the necessary functional units belonging to a production plant and gives an example that illustrates how GMP criteria are considered in plant design. It addresses questions that arise when designing a plant, such as the whether a plant should be tailor‐made for a single product or be multi‐functional. The chapter discusses basic concepts such as disposable technology, flexible piping, and fractal versus integrated construction. It talks about the large area of clean media and other utilities necessary for facility operation. The chapter describes typical cleaning protocols and installations, and provides an overview over the main design criteria for clean‐rooms. It outlines the challenges and general approaches to process automation for biotech production. Quality control laboratories are the most important support function for the production plant. The chapter discusses criteria for the selection of a site for a manufacturing facility.