ISPE Publishes ISPE APQ Guide: Management Responsibilities & Review (MRR)

04 August, 2021

APQ Guide: Management Responsibilities & Review (MRR)ISPE announced the release of its latest Guide, 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 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.

Leadership Coach, GMP Consultant
Engineering Systems 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.


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