Good Practice Guide: Maintenance

Author(s): Calitri, Chaz; Orombelli, Pietro; Adrian, Lawrence; Augen, Alberto; Bradney, Martin; Brodowski, Tom; Cappelle, Thomas; Clark, Dennis; Jackson, W. Michael; Jordan, Mark; Lennon, Robert; Ranieri, Tonino; Rodriguez, Constantino; Rolandi, Claudio; Styles, Andrew; Wessel, Mark; Wittmann, George

The ISPE Good Practice Guide: Maintenance provides practical solutions and tools for ensuring quality and compliance of maintenance operations in a regulated industry. Covering current and established practices, this guide helps achieve technical and regulatory accuracy and cost-effective compliance in a new or an existing maintenance program for effective strategy and efficiency. Offering maximum flexibility, this guide clearly helps define roles and responsibilities across cross-functional areas and recommends a systematic approach aimed at continuous improvement of maintenance operations. The Guide is focused on maintenance in cGMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program. The Guide seeks to enable widespread adaptation and encourage innovation.