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30 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Summit Art Creations - stock.adobe.com M anufacturing performance determines quality of outputs. When a company ex- periences significant manufacturing per- formance issues, improvements to pro- duction design are typically needed. Many industries have demonstrated the value gained from improving manufacturing capabilities, from both quality and business perspectives. However, in the pharmaceuti- cal industry, the business costs and benefits that dis- tinguish manufacturing choices are not always suffi- ciently understood and described when design options are weighed. When unreliable operations are used to produce medicines, the consequent lower assurance of quality can impact multiple stakeholders, including but not limited to manufacturers, the healthcare sys- tem, patients, and governments. To support selection of appropriate manufacturing technologies in accord with the principles of ICH Q9(R1) Quality Risk Manage- ment, the pharmaceutical industry would benefit from wide adoption of comprehensive models that better quantify the business benefits of investing in qual- ity. This paper explores the state of pharmaceutical manufacturing as well as lessons learned from vari- ous industries who have realized long-term financial benefits of enhanced production capabilities, based on a literature search and survey data. It concludes by ICH Q9: Aligning ROI, Quality Risk Management, QRM, and Pharmaceutical Innovation Rick L. Friedman is Deputy Director, Manufacturing Quality, in the Office of Manufacturing Quality, CDER, FDA. David Lebo is TITLE at Temple University. Lawrence Liberti is TITLE at Temple Univerity, and GK Raju is TITLE at MIT This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.