ISPE Briefs: New APQ Guide Develop a Robust and Efficient Change Management System
Marcy Sanford
Effective and timely management of change throughout the product life cycle enables quality improvement and is critical to patient safety, supply reliability, and operational effectiveness and efficiency. The ISPE Advancing Pharmaceutical Quality (APQ) Guide: Change Management System provides a quality management framework for assessing and advancing change management (CM) system maturity level by evaluating areas such as CM documentation, CM metrics, governance, management oversight, and more.
Pharmaceutical companies are required to have a change management system in place, but an inadequate one may result in ineffective changes that require rework or missed opportunities. This guide focuses on how to evaluate and optimize the system a company has, provides tools that can be used to improve the system, and offers guidance on how to improve and develop a change management system that is appropriate to a company’s maturity level.
This is the third guide in the APQ Guide Series, which is part of ISPE’s Advancing Pharmaceutical Quality initiative. The APQ Guide Series is aligned with international initiatives that promote quality excellence, as well as the FDA’s interest in quality management maturity. Other guides in the series explore corrective action and preventive action (CAPA), management responsibilities and management review, and process performance and product quality monitoring systems.
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Anna Riley, Membership Operations Manager.
Tell us about your role at ISPE: what do you do each day?
I lead our Member Services team, who you have likely interacted with over the phone, via email, and at conferences. We work together to make every interaction with ISPE a great interaction. I also manage ISPE Engage to keep it a strong peer collaboration benefit for our members.
What do you love about your job?
My job offers me the opportunity to collaborate and create with almost every ISPE staff member in an effort to better serve our members. I absolutely love building relationships and getting creative with not only the ISPE team, but also with our membership. I am fascinated by the work you all do to shape the future of pharma!
What do you like to do when you are not at work?
I love spending free time with my husband and our seven-year-old daughter. We like to hunt down live music events, get together with friends, and explore our beautiful city of Tampa, Florida. As a trained yoga teacher, I also spend a good amount of time practicing yoga either at home or in group class settings. Namaste!
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and validation services, software assurance, and custom artificial intelligence solutions for biotech companies. With a degree in bioprocessing science and more than 12 years of experience in computer system validation and quality assurance, Patel has worked with cell and gene therapy companies,...
Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his career at Duferco Engineering in energy generation, then moved to Comecer Group, holding roles as project and product manager, and global sales manager for the pharma and advanced therapy medicinal product (ATMP) division. He eventually joined Omnia Technologies Group establishing the Omnia Life...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Xuandai Hoang, Senior Member Services Coordinator in the Membership Department.
This is the third guide in the APQ Guide Series, which is part of ISPE’s Advancing Pharmaceutical Quality initiative. The APQ Guide Series is aligned with international initiatives that promote quality excellence, as well as the FDA’s interest in quality management maturity. Other guides in the series explore corrective action and preventive action (CAPA), management responsibilities and management review, and process performance and product quality monitoring systems.
