May / June 2021

ISPE Briefs: New Edition of Good Practice Guide on Maintenance Is Available

Marcy Sanford
ISPE Briefs: New Edition of Good Practice Guide on Maintenance Is Available

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes, and maintenance programs have long been recognized as critical to the success of the operations they support.

Good Practice Guide: Maintenance 2nd EditionThe ISPE Good Practice Guide: Maintenance, Second Edition, can be used as a tool for the development, implementation, and execution of maintenance programs. It focuses on achieving cost-effective compliance while describing current established practices. This edition reflects alignment with the ICH Q9 risk-based approach with respect to maintenance and the industry as a whole.

“Since the first edition of the Guide was published, new and more efficient maintenance practices, trends, and technologies have been developed, while at the same time, the ICH Q9 risk-based approach has been adopted worldwide,” said Guide Co-lead Constantino Rodriguez, Director of Engineer-ing, Catalent Cell & Gene Therapy.

Guide Co-lead Peniel Ortega, Managing Director, Pharm Allies, added, “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.”

The Guide is focused on maintenance in GMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program. Other updates to this edition include consolidating basic and good practice categories, adding clarification on terminology for users, and updating examples.

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Meet the ISPE Staff: Kirsten Miller

Kirsten Miller

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Kirsten Miller, Continuing Education Program Manager, Program Development, in the Continuing Education department.

Tell us about your role at ISPE: what do you do each day?

My primary responsibility is managing program design, development, and delivery within an established business plan and timelines. It is crucial to engage, collaborate, and cooperate with industry professionals, regulators, colleagues, vendors, and other partners daily to successfully execute these programs each year.

Communication is key—hundreds of emails, conference calls, calendar appointments, and task reminders to planning committee members, speakers, and session leaders, all of whom have volunteered their time and expertise to ISPE.

What do you love about your job?

My colleagues and I have such great respect for each other, and the volunteers are wonderful, smart, interesting people. I am passionate about professional education and lifelong learning, and it is very satisfying to provide educational opportunities to the industry with valuable, relevant material, developed by extraordinary professionals.

What do you like to do when you are not at work?

I like spending time with family. I have two teenage sons and a 1-year-old golden retriever, Hemingway. I enjoy paddleboarding with my son, “taste-testing” some local brews, attending a concert-in-the-park event, or practicing yoga. I have family in Sarasota, and we visit as much as possible.