ABSTRACT
Analytical procedures provide the instructions that ensure consistent use of laboratory equipment, solution preparation, measurement recording, and documentation. In this chapter, qualification of such procedures is considered by using the approaches and statistical tools of analytical quality by design (aQbD) in the life cycle of an analytical procedure. This life cycle approach is based on processes, terms, and techniques that ensure adequate risk analysis is performed, thus reducing the chance of failure and ensuring that an analytical procedure is fit for its intended use. Focus is on Stage 2 of the life cycle: Procedure performance qualification. In particular, this chapter describes how to qualify analytical performance characteristics of accuracy, precision, and limit of detection. Examples are provided for both small molecule and large molecule products.
