A risk analysis for production processes with disposable bioreactors.

: Quality management systems are, as a rule, tightly defined systems that conserve existing processes and therefore guarantee compliance with quality standards. But maintaining quality also includes introducing new enhanced production methods and making use of the latest findings of bioscience. The advances in biotechnology and single-use manufacturing methods for producing new drugs especially impose new challenges on quality management, as quality standards have not yet been set. New methods to ensure patient safety have to be established, as it is insufficient to rely only on current rules. A concept of qualification, validation, and manufacturing procedures based on risk management needs to be established and realized in pharmaceutical production. The chapter starts with an introduction to the regulatory background of the manufacture of medicinal products. It then continues with key methods of risk management. Hazards associated with the production of medicinal products with single-use equipment are described with a focus on bioreactors, storage containers, and connecting devices. The hazards are subsequently evaluated and criteria for risk evaluation are presented. This chapter concludes with aspects of industrial application of quality risk management.