APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)


Member Price
Non-Member Price

Published: September 2022
Pages: 154

What is the current state of your organization’s Process Performance and Product Quality Monitoring Systems (PPPQMS)? 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.” In addition to maintaining a state of control, an effective PPPQMS enables continual improvement and is key to proactively identifying the need for product quality and process improvements or opportunities for variability reduction based on routine trend reviews.

The ISPE APQ Guide: Process Performance and Product Quality Monitoring System (PPPQMS) provides a quality management framework for assessing and advancing an organization’s PPPQMS maturity level by evaluating the following aspects:

  • 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

The ISPE PQLI® Guide: Part 4 – Process Performance and Product Quality Monitoring System focuses on what a PPPQMS is. This ISPE APQ Guide: PPPQMS focuses on how to evaluate and optimize the system that a company has.

The ISPE APQ Guide: PPPQMS is the fourth 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 elements:

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: PPPQMS focuses on application of the APQ framework to the PPPQMS.

Guide Core Team

Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH
Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
Tami J. Frederick
Senior Director, Corporate Quality Systems & Cultural Excellence
APQ Advisor
Theresa Allyn
Senior Director, Global QA
F. Hoffmann-La Roche
Maneesha Altekar, PhD
Technical Director, Business Strategy & Operations
Placeholder Person Graphic
Rafael Beerbohm
Head of Regional Quality Animal Health Biologicals Europe
Boehringer Ingelheim Pharma GmbH & Co KG
Bethany Glyde
Head of Global Quality Compliance
Eric Kwei
Principal Engineer
Moderna Therapeutics
Georgina McLeod, PhD
Associate Director
AbbVie Inc
Maurice B. Parlane, B Tech MIT
New Wayz Consulting Ltd/CBE Pty Ltd
Cenk Undey, PhD
Vice President, PTD Data and Digital