APQ Guide: Cultural Excellence

Published: November 2022
Pages: 200

• Table of Contents
• Special Pricing for Emerging Economies

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:

• Corrective and Preventive Action system
• Management responsibilities and management review
• Change management system
• Process performance and product quality monitoring system
• Cultural Excellence

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.

Guide Core Team

Erika A. Ballman

Associate Director Corporate Quality Systems

Perrigo Company Plc

Nuala Calnan

CEO

Biopharm Excel Ltd

Maria Amaya, PhD

Lead External Advocacy North America (Quality Policy)

Genentech, A Member of the Roche Group

Robert Brian Cutler, Jr.

Associate Director of Regulatory Compliance

Janssen

Tami Frederick

Senior Director, Corporate Quality Systems & Cultural Excellence

Perrigo

Apneet Hayer

F Hoffmann-La Roche AG

Harry Jeffreys

VP Pharmaceutical Quality Operations

Bausch + Lomb Inc - Bridgewater, NJ

Christine Teipen Smith

Executive Director - Global Quality Systems

Eli Lilly And Company