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 quality management framework for assessing and advancing leadership systems. It provides a systematic and proactive approach to evaluating management responsibilities highlighted in ICH Q10 as well as other key leadership components:
Management of Outsourced Activities and Purchased Materials
Management of Change in Product Ownership
Regulatory and Industry Awareness
The ISPE APQ Guide: Management Responsibilities and Management Review 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.
Note: Each Guide in the APQ Guide series contains two parts. Part 1 covers the key principles of the APQ program and explains the Assess, Aspire, Act, and Advance framework. This prerequisite information is applicable to all PQS elements and is common across each of the APQ Guides. Part 2 of the ISPE APQ Guide: Management Responsibilities and Management Review covers the practical application of the APQ framework to leadership.
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.
The APQ Guide Series provides a practical set of tools and systematic approaches for organizations to proactively advance the maturity and effectiveness of the following PQS elements:
Each area will be covered in depth using the APQ framework of Assess, Aspire, Act, and Advance, providing tools and Key Performance Indicators (KPIs) for organizations to incorporate into their quality program. Each Guide contains quantitative and qualitative tools to assess the organization’s current state of quality, diagnose gaps, and identify improvement targets – Assess and Aspire. The Guides will discuss using this information to develop an Improvement Action Plan that the organization can execute and evaluate for effectiveness – Act and Advance. The ISPE APQ Guide: Management Responsibilities and Management Review focuses specifically on application of the APQ framework to leadership systems.
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*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply: