ABSTRACT
Quality impacts every aspect of a biotechnology operation. While this might seem like a bold statement, those involved in biotechnology would certainly agree it is true. The requirement for quality in biopharmaceutical development is backed by a host of regulations (see Chapter 3 and Chapter 4). As applied to biotechnology operations, a state of quality is necessary in all endeavors and quality increases the value of services and products. We refer to quality systems, quality by design, quality control and the roles of quality in compliance to name but a few quality terms. Indeed, the word quality has various meanings to different individuals and for each situation in which the word is used, so it is perhaps best dened in the context of each usage. This book tries to do just that. Yet, we need to begin this chapter on quality systems by establishing a basic denition for quality. The reader might take his/her choice from any one of ve denitions given below.
