ABSTRACT
This chapter deals with an introduction of the most commonly used control charts, followed by a discussion of the construction of control charts based on Bayesian methods. It discusses a few control charts commonly used in drug manufacturing. The chapter demonstrates the applicability and computational ease of Bayesian methods. Bayesian methods provide a flexible framework that blends prior knowledge of a process with current data. The Bayesian approaches, however, are unfamiliar to quality engineers and statisticians in pharmaceutical manufacturing. Bayesian methods provide a means to make full use of the historical data. In addition, a Bayesian approach also results in a probabilistic statement of how likely Out-of-speciation (OOS) results is to be a true outlier. The historical data of the manufacturing process that operated in a state of control provide a useful canvas for evaluating the OOS result and deciding on the disposition of the batch under evaluation.
