ABSTRACT
Quality control (QC) is a laboratory endeavor aimed at ensuring that the highest quality biotechnology products are manufactured and released to users. It requires careful planning and coordination with other functional areas, notably biomanufacturing. Quality control tests do not just happen, they are designed for a specic purpose following principles of Quality by Design or QbD (see Chapter 5). QbD promulgates concepts of a superior quality testing program and it is based on an understanding of the product and the analytical tools used to test it. Laboratory tests are designed to meet certain objectives and quality standards. This chapter reviews principles of quality control planning, describes the life cycle of product test and speci-cation development, identies analytical methods most often applied to biopharmaceutical development, discusses the qualication and validation of these methods and mentions the application of quality control tests for product release and stability.
