ISPE APQ Case Study and FDA QMM Program Learnings. The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry expert representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself to provide a range of sustainable and practical quality management improvement strategies. This ISPE Advancing Pharmaceutical Quality Program is a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness. It has been developed to support organizations to Assess, Aspire, Act and Advance the maturity and effectiveness of their quality management. It provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System. Further, FDA will share learnings from FDA QMM Pilot studies and risk management model studies in partnership with St. Gallen University. 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 QMM program entails quality system assessment, performance measures, improvement tools for advancement, and case studies for robust application. Training for the ISPE APQ program will begin in 2023 where our expert team will share practical examples and case studies of the five guides in action.
1015 – 1040: FDA Quality Management Maturity Program Learnings by Marcus Yambot 1040 – 1055: Quality Management Maturity in Action! ISPE Advancing Pharmaceutical Quality Program by Michael Grischeau 1055 – 1145: APQ Case Study by Maria Amaya, Michael Grischeau, Andrew Denny, Christine Moore, Christian Woelbeling and Bethany Glyde
Lead External Advocacy North America (Quality Policy),
Genentech, A Member of the Roche Group
Senior Director, Governance & Performance Management,