PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends

If FDA is going to establish standards for assessing the quality of manufacturing sites and products, it should seek data on a few well-defined measures that reflect longer-term results and trends, rather than “snapshots of current numbers.” And such metrics should include more leading-vs. lagging-indicators to reflect a firm’s commitment to continuous improvement in production processes. Those recommendations come from a PDA “points to consider” paper, written to help FDA set standards to measure product quality and manufacturing capabilities.

The recommendations were compiled by a committee of experts representing all aspects of the biopharmaceutical industry who participated in a December 2013 PDA conference on the issue. The panel specifically proposes that FDA seek data on quality complaint rates, batch reject rates and confirmed out-of-specification

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To help FDA implement this quality measurement program, PDA proposes to conduct a pilot project to collect metric data. This pilot project could help identify issues and challenges that FDA should address upfront and to assess the ease of

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Manufacturers hope this initiative will be beneficial by helping to control drift, to steer inspections to high-risk situations, and to prevent problems that could lead to drug shortages. Yet industry fears unintended consequences: Using metrics to directly compare production sites and products could prompt manufacturers to focus more on achieving certain rates, as opposed to achieving

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