ABSTRACT
This chapter provides an overview of the regulatory requirements of current Good Manufacturing Practices (cGMPs) and describes the importance of cGMPs when designing engineering processes within a pharmaceutical facility. All pharmaceutical manufacturing companies have similar objectives related to the planning, designing, building, validating, and maintenance of their facilities, including the following: (1) design, delivery, and maintenance of manufacturing support facilities, utilities, process equipment, and automation controls so that they perform as intended to meet business objectives, such as capacity, yield, operational efficiency, and reliability; (2) development of a production process that can repeatedly produce a quality product; (3) creation of a quality system necessary to meet regulatory as well as business requirements; and (4) project and process deliveries that are within budgets and schedules. These objectives need to comply with regulations while retaining a highly competitive position.
