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# 11 Drug Quality Metrics Proposed by Xavier/PWC
- URL: https://www.fdaweb.com/11-drug-quality-metrics-proposed-by-xavier-pwc/
- Published: 2016-03-15T12:00:00.000Z
- Updated: 2026-09-15T02:43:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135087

> Xavier University and PricewaterhouseCoopers have identified 11 drug quality risk metrics linked to patient safety that could be viewed during an FDA inspection. According to a just-posted [Pharmaceutical Quality Metrics White Paper](https://www.pwc.com/us/en/health-industries/pharma-life-sciences/publications/assets/xavier-whitepaper.pdf?ref=fdaweb.com), the metrics were developed by a team of 31 industry professionals as a tool that stakeholders across industry could use to inform decisions and take action. “It is built upon driving a mindset of continuous improvement that includes feedback loops across the entire enterprise to design quality in product proactively at the source, instead of reactively catching bad quality after manufacture,” the paper says.  
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> The team recommended that the metrics framework be incorporated into FDA’s inspection protocol as a roadmap for investigators to evaluate drug manufacturing and control operations during an inspection. It assessed metrics for each production phase (pre-production, production, and post-production), mapped the metrics against quality system elements, compared them against critical customer requirements through the use of a cause and effect matrix, created a total product lifecycle framework for the metrics, and determined the appropriate calculations for each metric.  
>  
> One of the metrics is the percentage of process validation batches without deviations related to product and process development, according to the paper. The team concluded that by measuring the success of the process validation batch runs, companies could get a better sense of how well the product and processes had in fact been characterized and in turn, the level of quality that would be achieved once the product was released commercially.  
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> Another metric measures the percentage of analytical methods transferred without analytical method development deviations. This metric was proposed to help organizations assess the rigor of the analytical method development process for the current and future products. “Often, analytical methods are improved during the transfer process without assessing the rigor of analytical method development across the board,” the paper says. “This metric will help highlight the success of ‘right first time’ in analytical method development, which can trigger continual improvement that reduces opportunity for analytical error.”