Good Practice Guide: Maintenance 2nd Edition


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Published: January 2021 
Pages: 132

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. This Guide is focused on maintenance in GMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program.

Since the first edition of this Guide, the ICH Q9 risk-based approach has been widely adopted worldwide. This edition reflects alignment with the risk-based approach with respect to maintenance and the pharmaceutical industry as a whole. Updates to this edition include consolidating basic and good practice categories, adding clarification on terminology for users, and updating examples.

Guide Team

Peniel Ortega
Managing Director
Constantino Rodriguez
Director Facilities & Engineering
Daniel G. Franklin, CIRM, CxA
Associate Director, Compliance Services
Thomas Harris, ME, AE
Reliability Engineering Manager
Placeholder Person Graphic
Michael Lacey
Engineering (Operations) Manager
Mylan Global Respiratory Group
Tim Lai
Facilities Director
Stephan Neumann
Global Governance Critical Utilities
Boehringer Ingelheim GmbH
Hamid Teimourian
Energy Program (Sustainability) Lead
Alfred Ao Yu
Senior Director Engineering & Facilities
Resilience Biotechnologies Inc