Concurrent Session: Robust APQ and FDA Quality Management Maturity

Concurrent Session: Robust APQ and FDA Quality Management Maturity| ISPE is aligned with FDA’s vision of the value of QMM and initiated the ISPE Advancing Pharmaceutical Quality (APQ) program in 2018 as an industry-led approach to advance pharmaceutical quality. The basic framework of the program is to “assess, aspire, act and advance” quality maturity based upon international ICH Q10 standards.

The APQ program, which is scheduled to be completed in 2022, provides a framework for assessing and enhancing the effectiveness of the Pharmaceutical Quality System (PQS). The program consists of five Good Practice Guides, one for each of the four elements of an ICH Q10 Pharmaceutical Quality System, a foundational Cultural Excellence Guide, and bookended by an optional benchmarking tool developed by University of St. Gallen. Three guides have been published and are available to use: Corrective Action and Preventive Action, Change Management System, and Management Responsibilities and Management Review. The fourth guide, Process Performance and Product Quality Monitoring System, is scheduled to be published in 2022. The 2017 ISPE Cultural Excellence Report will be converted into a fifth APQ Guide with enhanced features and case studies and also is scheduled to be published in 2022.  In this interactive session, ISPE APQ team will deep-dive into the final two guides:  Cultural Excellence and Process Performance & Product Quality Monitoring System.

ISPE supports 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.  A robust QMM program should entail assessment, measures, improvement tools for advancement, and case studies for application.