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?
-The objective of this project is to explore a means to deliver an effective measurementprocess by proposing and evaluating potential quality metrics candidates appropriate formonitoring 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 theexisting manufacturing controls; the performance of key manufacturing operations and thehealth of the overall quality culture within pharmaceutical organizations. Given the recentincrease in interest; across both the regulatory and industry communities; and the pace ofinnovation in a variety of metrics initiatives; it is recommended to review the researchoutcomes at the end of year one before planning next step activities for year two.
