The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE Good Practice Guide: Maintenance, 2nd Edition. The Guide describes current established good practices 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 new edition reflects alignment with the ICH Q9 risk-based approach with respect to maintenance and the industry as a whole. Updates include consolidating basic and good practices categories, adding clarification on terminology for users, and updating examples.
“Since the first edition of the ISPE Good Practice Guide: Maintenance was published, new and more effective and efficient maintenance practices, trends, and technologies have been developed while at the same time the ICH Q9 risk-based approach has been adopted world-wide,” said Guide Co-Lead Constantino Rodriguez, Director of Engineering, Catalent Cell & Gene Therapy.
“In the second edition, we seek to provide guidance on the latest trends in maintenance programs, recommend flexible, standard practices that can be applied globally, and offer suggestions to control the escalation of non-value generating requirements and costs,” added Guide Co-Lead Peniel Ortega, Managing Director, PharmAllies.
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.
