Key Research Aims: The project will seek to improve the scientific knowledge and technical capability of organizations to collect and report on the recommended set of quality metrics, which shall provide objective ?measures of quality? from both a product perspective and at a manufacturing facility or site. The desired outcome of this research project is to induce and encourage the right behavior and responsibility for industry, to enable more effective surveillance of the state of an organizations? quality by FDA, while promoting improved product and process capability. The selected set of quality metrics should also support the aim of achieving enhanced product quality without the need for extensive regulatory oversight and ultimately help to drive responsibilities for the manufacturers that lead to a reduction in product-related shortages and quality related recalls. Finally, the concepts and methods proposed should also build upon a fundamental excellence strategy, by promoting the use of industry benchmarking of selected quality metrics as a means to influence and positively impact on key quality outcomes across a network of industry peers. The St.Gallen Proposal: This research proposal aims to build upon, adapt and improve the existing Operational Excellence (OPEX) research from the University of St. Gallen in order to address the current needs of the FDA/OPQ quality metrics initiative. This research team will investigate widely known excellence frameworks and detail the evaluations on the basis of existing data from within the St.Gallen OPEX benchmarking database. Furthermore, it will use well- researched data analysis methods and tools to examine and demonstrate significant relationships between identified Quality Enablers and quantifiable Quality KPIs. This evaluation will facilitate understanding the interdependencies between Enablers and KPIs from a systems perspective that recognize the challenges inherent in the current pharmaceutical global supply chain. References: US Congress. (2012). FDASIA -Public Law 112-144 (112th Congress). FDA, CDER. (2015). Request for Quality Metrics, Guidance for Industry.

Public Health Relevance

- The objective of this project is to explore a means to deliver an effective measurement process by proposing and evaluating potential quality metrics candidates appropriate for monitoring the status of both product and facility quality across the inventory of FDA- regulated sites. The quality metrics proposed shall seek to establish the effectiveness of the existing manufacturing controls, the performance of key manufacturing operations and the health of the overall quality culture within pharmaceutical organizations. Given the recent increase in interest, across both the regulatory and industry communities, and the pace of innovation in a variety of metrics initiatives, it is recommended to review the research outcomes at the end of year one before planning next step activities for year two.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZFD1)
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Hughes, Kathryn
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University of Sankt Gallen
Sankt Gallen
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