ABSTRACT
In the pharmaceutical industry, there is a legislative imperative to satisfy all regulatory requirements relating to the safety, quality and efficacy of the product for the protection of the patient. Product-driven quality system is based on the belief that the product will be of sufficient quality and will comply with regulatory expectations provided that all procedures and tests are followed to the letter. This chapter reviews the concepts of quality control and quality assurance in order to define the interaction between them. Quality controls are the points designed to reveal deviation from the purpose and design of a process from a statistical or cosmetic perspective. The chapter describes the appropriate determination of control limits that have been published both within and outside the pharmaceutical literature. For effective process design and management, it is necessary to take a process-driven approach to the quality system. Effective process management begins with identifying both the quality control and quality assurance points of the process.
