ISPE Publishes ISPE Good Practice Guide: Maintenance

11 February, 2021

 

ISPE Publishes ISPE Good Practice Guide: Maintenance

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 worldwide

Co-Lead

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

Co-Lead

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.

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Guide Team

Peniel Ortega
Managing Director
PharmAllies
Co-Lead
Constantino Rodriguez
Director, Engineering
Catalent Cell & Gene Therapy
Co-Lead
Daniel G. Franklin, CIRM, CxA
Manager, Compliance Services
IPS
Thomas Harris, ME, AE
Regional TPM Reliability Lead
AstraZeneca
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Michael Lacey
Engineering (Operations) Manager
Mylan Global Respiratory Group
Tim Lai
Facilities Manager
Boehringer Ingelheim
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Stephan Neumann
Global Governance Critical Utilities
Boehringer Ingelheim GmbH
Hamid Teimourian
Facilities Director
AstraZeneca
Alfred Ao Yu
Senior Director Engineering & Facilities
Resilience Biotechnologies Inc