ISPE Advancing Pharmaceutical Quality Guide: Change Management System cover image

ISPE Advancing Pharmaceutical Quality Guide: Change Management System

Published:February 2022

Pages:152

What is the current state of your organization’s Change Management (CM) System? The effective management of change throughout the product lifecycle enables quality improvement and is critical to patient safety, supply reliability, as well as operational effectiveness and efficiency.

“Pharmaceutical companies are required to have a Change Management System in place, but an inadequate one may result in ineffective changes that require rework or missed opportunities,” said Guide Lead Lori Chelemedos, Founder/Principal Consultant Pac-Side LLC. “This Guide focuses on how to evaluate and optimize the system a company has, provides tools that can be used to improve the system, and offers guidance on how to improve and develop a Change Management System that is appropriate to a company’s maturity level.”

The ISPE APQ Guide: Change Management System provides a quality management framework for assessing and advancing CM system maturity level by evaluating:

  • CM Documentation
  • Change/Scope Identification
  • Change Rationale, Impact/Level, and Risk
  • Change Plan/Execution
  • Post-Change Evaluation
  • CM Metrics
  • Governance, Management Oversight, and CM Prioritization

The ISPE PQLI® Guide: Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System focuses on what a CM system is. This ISPE APQ Guide: Change Management System focuses on how to evaluate and optimize the system that a company has.

The ISPE APQ Guide: Change Management System is the third in the planned four-part series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. The Guide Series is part of ISPE’s newest 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 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 will contain 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: Change Management System focuses on application of the APQ framework to the CM system.

  • 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 the Change Management System (APQ-CM)
  • 5 Introduction to APQ-CM
  • 5.1 Key Concepts of the Change Management System
  • 5.2 Performance Management of the Change Management System
  • 5.3 Personnel Competency Development: Knowledge, Skills, and Behaviors for Effective Change Management
  • 5.4 Seven Sub-Elements of the APQ-CM System
  • 6 APQ Assess Phase
  • 6.1 Assessing Sub-element 1 – CM Documentation
  • 6.2 Assessing Sub-element 2 – Change/Scope Identification
  • 6.3 Assessing Sub-element 3 – Change Rationale, Impact/Level, and Risk
  • 6.4 Assessing Sub-element 4 – Change Plan/Execution
  • 6.5 Assessing Sub-element 5 – Post-Change Evaluation
  • 6.6 Assessing Sub-element 6 – CM Metrics
  • 6.7 Assessing Sub-element 7 – Governance, Management Oversight, and CM Prioritization
  • 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 the CM System
  • 13 Appendix 4 – APQ Catalog of Improvement Resources and KPIs for the CM System
  • 13.1 Metrics
  • 13.2 Recommended Improvement Tools
  • 14 Appendix 5 – Example APQ-CM Assess and Aspire Report
  • 15 Appendix 6 – Example Template for APQ-CM 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
  • Lori Chelemedos (Lead), Pac-Side LLC, USA
  • Andrew Denny, Bristol-Myers Squibb, USA
  • Denise DiGiulio, Johnson & Johnson, USA
  • Tami Frederick (APQ Advisor), Perrigo, USA
  • Tim Huber, Eli Lilly & Co., USA
  • Harry Jeffreys, Bausch Health Companies, USA
  • Jennifer Peszek, Pfizer Inc., USA
  • Clayton Lee Spillman, Pfizer Inc., USA
  • Jo Anne Valentino, Minaris Regenerative Medicine, 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 four PQS elements that are based upon ICH Q10:1

  • CAPA system [2]
  • Management Responsibilities and Management Review (MRR) [3]
  • Change Management (CM) system
  • Process performance and product quality monitoring system

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 elements.

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

1 The APQ Guide for the process performance and product quality monitoring system is a planned future ISPE publication.