ISPE Advancing Pharmaceutical Quality Guide: Cultural Excellence cover image

ISPE Advancing Pharmaceutical Quality Guide: Cultural Excellence

Published:November 2022

Pages:200

Cultural excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. Culture determines quality outcomes by affecting the organization’s ability to identify and act upon near-miss shortages, ensuring the integrity of its data, assuring transparent problem escalation, and striving for operational excellence.

The ISPE APQ Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s culture of quality by evaluating the following aspects:

  • Leadership and Vision
  • Mindsets and Attitudes
  • Gemba and Employee Engagement
  • Leading Quality Indicators – Measuring What Matters
  • Proactive Oversight, Review, and Reporting
  • Cultural Enablers
  • Critical Third-Party Partnerships

This APQ Guide builds upon the insight provided in the ISPE Cultural Excellence Report  (2017) on quality culture improvements across six dimensions. The Report provided the “what” and why”, while this APQ Guide provides the “how”. The Report also outlined a series of practical and powerful approaches, practices, and tools for improving the impact of culture on the performance outcomes for an organization. It is a valuable companion to this APQ Guide.

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the 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.

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 topics that are based upon the principles and elements of ICH Q10:

Each area is 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 discuss how to use this information to develop an Improvement Action Plan that the organization can execute and evaluate for effectiveness – Act and Advance. The ISPE APQ Guide: Cultural Excellence focuses on application of the APQ framework to cultural excellence.

  • Part 1: The Advancing Pharmaceutical Quality (APQ) Program
  • 1 Introduction to the APQ Program and Guide Series
  • 1.1 Objectives
  • 1.2 Scope
  • 1.3 Benefits
  • 1.4 About the ISPE APQ Guide Series
  • 1.5 How to Use This Guide
  • 2 Understanding the APQ Program
  • 2.1 Link to the ICH Q10 PQS Model
  • 2.2 Link to Cultural Excellence and Operational Excellence
  • 3 APQ Assess, Aspire, Act, and Advance Framework
  • 3.1 APQ Framework Process
  • 3.2 APQ Self-Assessment Tool
  • 3.3 Cross-Functional Team Approach
  • 4 APQ Benchmarking
  • 4.1 Benchmarking Questionnaire
  • 4.2 APQ Pre-Assessment Benchmarking
  • 4.3 APQ Post-Action Benchmarking
  • Part 2: Practical Application of the APQ Framework to Cultural Excellence (APQ-Cultural Excellence)
  • 5 Introduction to APQ-Cultural Excellence
  • 5.1 Key Concepts
  • 5.2 Six Sub-Elements of APQ-Cultural Excellence
  • 5.3 Establishing and Maintaining Trusted Partnerships with Critical Third Parties
  • 6 APQ Assess Phase
  • 6.1 Assessing Sub-element 1 – Leadership and Vision
  • 6.2 Assessing Sub-element 2 – Mindsets and Attitudes
  • 6.3 Assessing Sub-element 3 – Gemba and Employee Engagement
  • 6.4 Assessing Sub-element 4 – Leading Quality Indicators – Measuring What Matters
  • 6.5 Assessing Sub-element 5 – Proactive Oversight, Review, and Reporting
  • 6.6 Assessing Sub-element 6 – Cultural Enablers
  • 6.7 Assessing Critical Third-Party Partnerships
  • 7 APQ Aspire Phase
  • 7.1 Evaluation of the Assigned Maturity Ratings
  • 7.2 Prioritization of Targeted Improvements
  • 8 APQ Act Phase
  • 9 APQ Advance Phase
  • Appendices
  • 10 Appendix 1 – APQ Program Drivers and Goals
  • 10.1 What Does Advancing Pharmaceutical Quality Mean?
  • 10.2 APQ Program Overarching Goals
  • 11 Appendix 2 – APQ Program History: From Quality Metrics to Advancing Pharmaceutical Quality
  • 12 Appendix 3 – APQ Maturity Assessment Tool for Cultural Excellence
  • 13 Appendix 4 – APQ Catalog of Improvement Resources and KPIs/KBIs for Cultural Excellence
  • 13.1 APQ Catalog for Cultural Excellence Sub-elements
  • 13.2 APQ Catalog for Critical Third-Party Partnerships
  • 13.3 Index of Additional Improvement Resources from ISPE Cultural Excellence Report
  • 14 Appendix 5 – Example APQ-Cultural Excellence Assess and Aspire Report
  • 15 Appendix 6 – Example Template for APQ-Cultural Excellence Improvement Action Plan
  • 16 Appendix 7 – APQ Benchmarking Tool
  • 17 Appendix 8 – Example APQ Benchmarking Report
  • 18 Appendix 9 – References
  • 19 Appendix 10 – Glossary
  • 19.1 Acronyms and Abbreviations
  • 19.2 Definitions
  • Maria Amaya, Genentech, A Member of the Roche Group, USA
  • Erika Ballman (Co-Lead), Perrigo, USA
  • Nuala Calnan, PhD (Co-Lead), BioPharm Excel Ltd., Ireland
  • Robert Brian Cutler, Jr., Johnson & Johnson, USA
  • Tami Frederick (APQ Advisor), Perrigo, USA
  • Apneet Hayer, F. Hoffman-LaRoche, Canada
  • Harry Jeffreys, Bausch + Lomb Inc, USA
  • Christine Teipen Smith, Eli Lilly & Company, USA

Advancing Pharmaceutical Quality (APQ) is a comprehensive program for assessing and improving an organization’s quality management maturity. It is an industry-led approach that seeks to advance pharmaceutical quality beyond the submission of data for harmonized, reportable metrics. Organizations can leverage this program to ensure a continuous supply of quality medicines to patients.

The APQ program evolved from the ISPE Quality Metrics Initiative which represents extensive industry engagement, collaboration with academia and other associations, and knowledge sharing with regulatory agencies. The APQ program is harmonized with international regulatory initiatives that promote quality excellence.

APQ is built upon the ICH Q10 Pharmaceutical Quality System (PQS) model [1] that comprises management responsibilities and the following PQS elements:

  • Process performance and product quality monitoring system
  • Corrective Action and Preventive Action (CAPA) system
  • Change management system
  • Management review of process performance and product quality

The APQ program further enhances this ICH Q10 model with cultural excellence and operational excellence (continual improvement) principles. Due to the interconnectedness of management responsibilities and management review, these are addressed together for the purposes of the APQ program. The APQ Guide Series focuses on the application of the APQ framework to these PQS topics that are based upon the principles and elements of ICH Q10:

  • CAPA system [2]
  • Management Responsibilities and Management Review (MRR) [3]
  • Change Management (CM) system [4]
  • Process Performance and Product Quality Monitoring System (PPPQMS) [5]
  • Cultural Excellence

The APQ Guide Series provides a practical set of tools and systematic approaches—the Assess, Aspire, Act, and Advance framework—for organizations to advance the maturity and effectiveness of these PQS topics.

This ISPE APQ Guide: Cultural Excellence 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 topics. Part 2 covers the practical application of the APQ framework to Cultural Excellence. Tools and examples are provided in the appendices. Additionally, a ZIP file containing the APQ Maturity Assessment Tool (for Cultural Excellence) and the APQ Benchmarking Tool is provided with this Guide at the time of purchase.