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ISPE Advancing Pharmaceutical Quality Program Complete

Tami J. Frederick
APQ Framework Overview

ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is now available with the release of the fifth and final guide.

APQ logoThe APQ Program is a quality management maturity assessment built by industry experts for use in industry prepares your organization for regulatory inspections and quality assessments when implemented fully by your own team. The program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s focus on quality management maturity and rating the maturity of manufacturing facilities.

The APQ program provides a framework for assessing and enhancing the effectiveness of the Pharmaceutical Quality System (PQS) as described in ICH Q10. The program consists of five Good Practice Guides: Corrective and Preventive Action, Management Responsibilities and Management Review, Change Management, Process Performance and Product Quality Monitoring, and Cultural Excellence.

The APQ program:

  • Recognizes that the ability to advance quality management maturity lies within the industry itself (developed by industry representatives for use by industry)
  • Builds upon the ICH Q10 model and enhances the PQS elements with the aspects of cultural excellence, operational excellence (OPEX), knowledge management, and continual improvement
  • Provides a comprehensive approach for assessing and improving an organization’s quality management maturity to advance the state of quality within the organization

The APQ program focuses on eight overarching goals:

  1. Integrate quality management maturity, cultural, and operational excellence principles, tools, and approaches
  2. Support and incentivize continual improvement
  3. Foster industry ownership of quality beyond compliance
  4. Promote effective and efficient use of resources
  5. Encourage self-improvement and supplier improvement
  6. Enable structured benchmarking, knowledge sharing, and learning among organizations
  7. Increase the reliability of supply for quality products
  8. Offer routes to delivering sustainable competitive advantage

The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents:

  1. Corrective Action and Preventive Action (CAPA): ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle.

    The ISPE APQ Guide: Corrective Action & Preventive Action (CAPA) System covers the practical application of the APQ framework for each CAPA system requirement by evaluating the following elements:
    • CAPA Documentation
    • Problem Identification
    • Root Cause Identification
    • Corrective and/or Preventive Actions
    • CAPA Effectiveness
    • CAPA Metrics
    • Governance, Management Oversight, and CAPA Prioritization

  2. Change Management System: ICH Q10 establishes clear guidance for the effective management of change throughout the product lifecycle which enables quality improvement and is critical to patient safety, supply reliability, as well as operational effectiveness and efficiency.

    The ISPE APQ Guide: Change Management provides a quality management framework for assessing and advancing Change Management system maturity level by evaluating:
    • Change Management Documentation
    • Change/Scope Identification
    • Change Rationale, Impact/Level, and Risk
    • Change Plan/Execution
    • Post-Change Evaluation
    • Change Management Metrics
    • Governance, Management Oversight, and Change Management Prioritization

  3. Management Responsibilities and Management Review: 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 and key leadership components by evaluating the following elements:
    • 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

  4. Process Performance and Product Quality Monitoring System: ICH Q10 establishes an expectation for pharmaceutical companies to “plan and execute a system for the monitoring of process performance and product quality to ensure a state of control is maintained.”

    The ISPE ISPE APQ Guide: Process Performance and Product Quality Monitoring System (PPPQMS) provides a quality management framework for assessing and advancing an organization’s PP&PQMS maturity level by evaluating the following elements:
    • Establishing a Control Strategy
    • Determining Tools for Measurement and Analysis of Parameters and Attributes
    • Analyzing Parameters and Attributes
    • Identifying Sources of Variation
    • Including Feedback on Product Quality from Internal and External Sources
    • Providing Knowledge to Enhance Process Understanding

  5. Cultural Excellence: The ISPE APQ Guide: Cultural Excellence shares insights on quality culture improvement across six key dimensions and outlines practical and powerful approaches, practices, and tools to support implementation of the cultural excellence framework and promote behavioural change that will ultimately benefit the patient and the business. It is based upon the 2017 ISPE Cultural Excellence report with enhanced features supporting key behavior assessment at employee and management levels, a robust recognition and reward program, and third-party contract evaluation. It provides a quality management framework for assessing and advancing Cultural Excellence maturity by evaluating the following elements:
    • Leadership and Vision
    • Mindsets and Attitudes
    • Gemba and Employee Engagement
    • Leading Quality Indicators with Metrics that Matter
    • Proactive Management Oversight, Review and Reporting
    • Cultural Enablers

ISPE enables industry to proactively demonstrate the value of quality management maturity which benefits regulators, industry, and patients. The ISPE APQ program is a voluntary, industry led program for QMM whereby industry can assess, aspire, act, and advance their level of quality management maturity and share it independently with their patients, consumers, customers, and health authorities globally, based upon international ICH Q10 standards. The APQ Program entails quality system assessment, performance measures, improvement tools for advancement, and case studies for robust application.

The APQ program was presented at an FDA Advisory Council Meeting on Quality Management Maturity on November 2, 2022. ISPE is aligned with FDA’s vision of the value of QMM and initiated the ISPE Advancing Pharmaceutical Quality (APQ) program as an industry-led approach to advance pharmaceutical quality.

Training for the ISPE APQ program will begin in 2023 with practical examples and case studies of the five guides in action.

Special Bundle Deal – Limited Time Offer!*

Save 30% on the APQ Guide Series 

*Valid 18 November 2022 – 31 January 2023. Must buy all five Guides in the APQ Guide Series in a single purchase. This offer cannot be combined with other offers or the Emerging Economy discount.

Member Price: $750
Non-Member Price: $1,800

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APQ Bundle