This second edition aligns with the ICH Q9 risk-based approach
The ISPE has released a 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 aiming to offer flexibility to enable widespread adaptation and encourage innovation.
This edition is intended to align 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, MD, PharmAllies.
The guide was written and reviewed by people working within the field, and is designed as a reference for the development, implementation, and execution of a maintenance program in a pharmaceutical manufacturing environment.