ISPE releases guide to management responsibilities and review

Published: 30-Jul-2021

The guide series is part of the society’s Advancing Pharmaceutical Quality initiative

The International Society for Pharmaceutical Engineering (ISPE) has announced the release of its latest guide: APQ Guide: Management Responsibilities and Management Review. This is the second publication in the APQ series, seeking to improve the state of pharmaceutical quality and ensure sustainable compliance.

The guide series is part of the society’s Advancing Pharmaceutical Quality initiative, a program designed for assessing and improving organisations’ quality management maturity. The guide was developed by members of the APQ Program which evolved from ISPE’s Quality Metrics initiative, representing industry engagement, collaboration with academia and other associations, and knowledge sharing with regulatory agencies.

ICH Q10 sets a clear expectation regarding the role of leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The APQ guide is designed to provide a systematic and proactive approach to evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components, including patient focus, quality planning, internal communication and more.

“This Guide provides a practical tool for organisations that want to assess and strengthen their leadership systems to support their pursuit of cultural excellence and ultimately create more value for their patients, shareholders, and employees,” said Guide Co-Lead Steven A. Greer, Executive Coach, Speaker and Consultant, Genesis Assist, LLC and ESi.

“Most scorecards do not include metrics focused on leadership effectiveness so drift can occur without warning signs and the results can be significant: drug shortages, enforcement actions, recalls, dissatisfied patients/consumers, and disengaged organizations. The APQ MRR Guide builds upon the framework of ICH Q10 with insights from industry leaders on what strong and effective leadership looks like,” said Guide Co-Lead Michael Grischeau, Director of Data Analytics and Management Review, AbbVie.

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