ISPE & the University of St.Gallen Sign MOU on Advancing Pharmaceutical Quality

25 June, 2020

ISPE and the University of St.Gallen, Switzerland, announced today that they had signed a Memorandum of Understanding (MOU) to collaborate on tools designed to advance the state of pharmaceutical quality.

ISPE’s Advancing Pharmaceutical Quality (APQ) Program is a quality maturity assessment and improvement tool based upon elements and principles identified in ICH Q10. The Program provides an “Assess, Aspire, Act and Advance” framework by which an organization can evaluate their current performance in each element and then set objective and measurable goals in an improvement action plan.

The Institute of Technology Management at the University of St.Gallen, Switzerland, has conducted more than a decade of research in Operational Excellence. The basis of this work is an Operational Excellence (OPEX) database created by the University of St.Gallen from data gathering, analysis, and benchmarking of more than 380 pharmaceutical manufacturing sites and around 100 QC Labs. This database provided the foundation for a three-year study of objective measures of quality under a USFDA research grant.

Under the MOU, the University of St.Gallen will develop a benchmarking tool designed especially for use with ISPE’s APQ Program. Used in conjunction with the ISPE Program, the pre- and post- benchmarking activities offer objective evidence of performance improvement. This combined effort by ISPE and the University of St.Gallen provides a powerful and comprehensive approach that organizations can leverage for continual improvement.

ISPE is pleased to partner with the University of St.Gallen to advance the state of pharmaceutical quality. This collaboration will further strengthen the efforts of ISPE's APQ program, which has involved extensive industry engagement and knowledge-sharing with multiple regulatory agencies.

“This partnership is a unique opportunity for our university to further advance research in the field of quality and operational excellence,” said Thomas Friedli, Director at the Institute of Technology Management and Professor for Production Management at St.Gallen University. “The collaboration will have a significant impact on the maturity of pharmaceutical quality management practices and lead to visible quality improvements across manufacturers.”

ISPE will publish the Advancing Pharmaceutical Quality Program with the St.Gallen APQ Benchmarking Tool in a series of Good Practice Guide modules: Corrective Actions and Preventive Actions (CAPA); Management Responsibilities and Management Review; Process Performance and Product Quality Monitoring System; Change Management System.

The first module, Corrective Actions and Preventive Actions (CAPA) is slated for release in late 2020.