The history of quality and quality management infrastructure mimics that of other industries. Deming believed it was management's job to create the right quality philosophy and architecture necessary to support the business. Certainly the Food and Drug Administration (FDA) has played a significant role in how the products are developed and how the product quality is defined. These improvements challenged us to examine closely the value of our Quality Assurance activities in terms of truly establishing product quality. Animal models are selected in an effort to detect overt drug toxicity. In addition, baseline pharmacokinetic (PK) and pharmacodynamic (PD) measurements are taken. These studies often give the initial indication of the drug's potential effectiveness. The overall quality management systems (QMS) must be aligned with a manufacturer's strategic plans to ensure that the system is part of the manufacturer's mission and quality strategies. The process documentation is a critical consideration for any Operational Excellence (OpEx) exercise.