Quality assurance signifies the entirety of measures to secure quality. Good manufacturing practice (GMP) signifies the portion of quality assurance dedicated to product manufacturing and testing. The benefit of quality assurance is understood intuitively when considering patient risk upon consumption of adulterated drugs. In the pharmaceutical field the implementation of a quality management system is a legal obligation. The state of the art as to quality systems is described in the guideline series ISO 9000 (9001–9004). The quality management system constitutes the organizational framework for documentation, application and surveillance of quality assurance measures. Documentation encompasses all fields of activity of quality assurance. During development of a product or the design of a technical facility, design control should ensure that the result does not bypass the client’s requirements. Design control can be applied to process and analytical development, clinical development, and technical planning of production plant.