ISPE Provides New Guidance on Change Management Systems

30 March, 2022

ISPE announced the release of the ISPE APQ Guide: Change Management System. This Guide provides a quality management framework for assessing and advancing change management (CM) system maturity level by evaluating documentation, change/scope identification, change rationale, 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.

The ISPE APQ Guide: Change Management System is the third in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive program for assessing and improving an organization’s quality management maturity.

Built upon the ICH Q10 Pharmaceutical Quality System (PQS) model, the APQ program is an industry-led approach that seeks to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. The program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s interest in quality management maturity and rating the maturity of manufacturing facilities, as cited in their 2019 Drug Shortages report. The result is a program that organizations can leverage to ensure a continuous supply of quality medicines to patients.

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