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!
In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, to address the barriers to technological innovation in the pharmaceutical industry. The first activity of the initiative was to conduct a three-part survey of ISPE members to understand the circumstances and confirm the sources that create barriers to...
Anil Mathai first heard about ISPE 30 years ago. “I attended Drexel University, where you are required to complete three cooperative education jobs. One of mine was for Rhône-Poulenc Rorer, Inc. in Collegeville, Pennsylvania. While I was there, I learned about validation and decided that I wanted to be in pharmaceuticals as a chemical engineer.”
After completing her doctoral degree at Oklahoma State University, Sarah Pope Miksinski received a fellowship at the National Institutes of Health. While working there, she realized that research was not the best career path for her.
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.
