ISPE publishes ISPE APQ Guide: Management Responsibilities and Management Review

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

The Guide Series is a part of the ISPE’s initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive programme for assessing and improving an organisation’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 evaluate the management responsibilities highlighted in ICH Q10 as well as other key leadership components like patient/consumer focus, management commitment, quality planning, internal communication, management of outsourced activities and purchased materials, management of change in product ownership, and regulatory and industry awareness.

Guide Co-Lead Steven A Greer, Executive Coach, Speaker and Consultant, Genesis Assist, LLC and ESi, Inc, said, “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.”

Adding to it, Michael Grischeau, Guide Co-Lead and Director, Data Analytics and Management Review, AbbVie Inc, said, “Most scorecards do not include metrics focussed 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 organisations. The APQ MRR Guide builds upon the framework of ICH Q10 with insights from industry leaders on what strong and effective leadership looks like.”