ABSTRACT
The safety, efficacy, and quality of a biological product is warranted through a set of effective control strategies, which include testing of raw materials, drug substance and product, in-process control, and manufacturing environment monitoring. Establishing specifications is at the heart of the overall control strategies and can be a formidable process. Recent advances in biopharmaceutical regulations ask for use of risk-based approaches to setting specifications. Such a method harnesses enhanced process and product understanding by synthesizing information from various sources, including nonclinical and clinical data from various stages of development of the product, analytical variability, process capability, and regulatory and compendial requirements. The purpose of this chapter is to discuss important considerations in setting specifications and associated statistical treatment. A special emphasis is given to specifications following the life cycle and risk-based principles.
