Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.

Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components.