ABSTRACT
This chapter reviews the principles of quality control (QC) planning, describes the life cycle of QC test and product specification development, and identifies analytical methods most often applied to biopharmaceutical development. It discusses the qualification and validation of these methods, and mentions the application of QC tests for product release and stability. The QC development cycle begins with a QC Plan, drafted only after there is an understanding of the intended product, a treatment indication, and at least an early or research version of the candidate biopharmaceutical. The heart of QC testing is developing and applying tests that measure a product’s attributes. Potency assays are critical to a QC testing scheme because they are used to predict whether the product will function as it was designed to function. The QC laboratory is often responsible for this environmental sampling and testing. Samples are taken during periods without manufacturing activity and also during actual manufacturing operations.
