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.
The ISPE Good Practice Guide: Maintenance, 2nd Edition focuses on achieving cost-effective compliance with existing regulations and associated guidance. It describes current established good practice and seeks to provide a practical and consistent interpretation of the required elements of a pharmaceutical Maintenance Program, while offering maximum flexibility to enable widespread adaptation and encourage innovation.
This Guide was written and reviewed by a group of experts in the field, making it a must-have reference for the development, implementation, and execution of a maintenance program in a pharmaceutical manufacturing environment.
