Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Overview

The ISPE APQ program has been developed by industry representatives, for industry use, to advance the current state of pharmaceutical quality. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself. A key driver for this program is to provide a range of sustainable and practical quality management improvement strategies. This structured framework provides practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can first be evaluated and then improved upon. Further, the APQ framework has been fully mapped against the US FDA QMM program rubric to ensure proactive preparedness for future success.

In this training, participants will be led through the APQ guide series for QMM including how to leverage the structured tools using a tested industry best-practice approach to coordinating, conducting, presenting, and reporting on assessment outcomes. Participants will learn how the APQ methodology is used to improve the current state of quality and how it can benefit their organization through the Assess, Aspire, Act, and Advance framework.

Course participants will interact with the model and tools over two days using real world examples. They will also have opportunities to exchange ideas on how to assess and improve the effectiveness of their own systems through shared experiences. Not only will participants walk away from the training with working knowledge of the model, but they will be equipped with additional bonus materials, including a master planner used to document the assessment structure (e.g. scoping, interview design, scheduling, and logistics) and a user-friendly electronic version of the Assess, Aspire, and Improvement Action Plan report templates.

QMM is defined as a way for drug manufacturers to integrate business and manufacturing operations with quality practices and technology to enhance product quality, supply chain reliability, and continual improvement. The concept aims to provide a higher assurance of product availability based on QMM assessments.

The APQ model is a qualitative and holistic measurement of behaviors and systems across multiple elements in the ISPE APQ Guides series, which consists of five ISPE Good Practice Guides: 

These are each bookended by an operational excellence benchmarking methodology developed by the University of St. Gallen.

The program is aligned with international initiatives that promote quality excellence, as well as with the US FDA’s interest in quality management maturity and ratings of the maturity of manufacturing facilities, as cited in their 2019 report, Drug Shortages: Root Causes and Potential Solutions. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies.

The APQ program offers a distinctive approach that enables manufacturers to prioritize and optimize the program's effectiveness by focusing on a specific element, multiple elements, or all elements. This flexibility allows users to tailor the program to their needs and goals, ensuring that they can achieve the desired outcomes efficiently and effectively.

Learn and understand how to assess and improve each element of the PQS as described in ICH Q10 using the APQ framework by signing up for the upcoming ISPE APQ QMM training, taking place 19 – 20 June, in Boston, Massachusetts. Walk away from this course with best practices for setting up and conducting an assessment and with practical tools to evaluate PQS effectiveness and help organizations drive toward continuous improvement.

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