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. The Guide was developed by members of the APQ Program which evolved from the ISPE Quality Metrics Initiative, representing extensive industry engagement, collaboration with academia and other associations, and knowledge sharing with regulatory agencies.

ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a systematic and proactive approach to evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components:

Patient/Consumer Focus

Management Commitment

Quality Planning

Internal Communication

Management of Outsourced Activities and Purchased Materials

Management of Change in Product Ownership

Regulatory and Industry Awareness

“This Guide provides a practical tool for organizations 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, Inc.

“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 Inc.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.