ISPE Briefs: New APQ Guide Develop a Robust and Efficient Change Management System
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.