quality

FDA and Quality Metrics in Biopharma

By: David R. Somers, Senior Industry Analyst

Moving Right Along 

The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA in improving product quality, reducing inspection costs, increasing the effectiveness of product monitoring, and streamlining reporting requirements have crossed the Rubicon of mere theorizing, discussion, and contemplation into firm and proactive steps. Those efforts have been aimed at the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution, and monitoring. These activities are in concert with the broader effort by FDA to promote innovation, increase stakeholder involvement in quality, and enhance the safety of the supply chain.

To support this initiative, the International Society for Pharmaceutical Engineering (ISPE) created a cohesive, comprehensive series of criteria for the measurement of critical parameters needed to define and control quality in biologic and pharmaceutical manufacturing.  Subsequently, using many of the metrics developed by the ISPE, the FDA submitted a draft guidance document called Request for Quality Metrics.

Continue reading the full article in Outsourced Pharma.

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