CPhI Worldwide proposes new FDA quality metrics system

CPhI Worldwide, organized by UBM EMEA, has announced the findings of part i of the 2016 CPhI Annual Report on potential new approaches to improve quality and manufacturing process in pharmaceutical production ahead of CPhI Worldwide 2016 in Barcelona. Five World-renowned experts—Ajaz Hussain, Girish Malhotra, Brian Carlin, Pabir Basu & Thomas Friedli—propose improved methods to how industry evaluate and consider quality in the pharmaceutical industry, making a number of key recommendations.

The overall findings reveal there are a number of improvements industry and the regulators can and should make to shift the industry from just meeting standards towards instilling continuous improvement and quality cultures across the board, which the panel predict will vastly improve overall quality and reduce manufacturing errors.

Prabir Basu, independent consultant and Prof. Thomas Friedli of the University of St. Gallen review a new systems based approach to quality metrics in their article—following the University receiving an FDA grant to undertake this. The goal is to recommend a measurement system based on St. Gallen’s Operational Excellence model, which encourages improved quality rather than lagging indicators that measure symptoms. The team, which also includes the Dublin Institute of Technology, state that these new metrics will “help the FDA to establish a clear standard for review and inspection, allowing for a risk-based regulatory approach, transforming quality oversight from a qualitative to a quantitative risk-based process.”