Search results for "metric"
Article
The Metrics of Quality Culture
Schniepp
The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July 28, 2015. The official title of this guidance for industry is Request f…
Article
Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
Article
FDA Seeks Metrics to Define Drug Quality
Seeking metrics
In crafting the shortages plan, an FDA Drug Shortages Task Force has been examining more broadly how drug manufacturing problems may precipitate plant closings and product discontin…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
This approach will be supported by a new quality metrics reporting initiative that requires biopharma companies to submit data on operations key to consistent quality production. FDA has been working …
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
These centers are designed to analyze data and provide insights for production forecasts, identify planning and risk metrics, and predict trends and areas of improvement across all of the company’s su…
Article
Drug Quality Key to Innovation and Access
An important initiative involves collecting metrics data from drug makers that give a more precise picture of how reliably a drug facility produces quality products. In late November 2016, FDA revised…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
The map then was designed to target these drivers using various metrics. While the most relevant metrics are still evolving, they will be useful in identifying specific deficiencies and eventually est…
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Framing Biopharma Success in 2016
Quality warning signs
FDA plans to use quality metrics to develop risk-based inspection scheduling of drug manufacturers; to improve its ability to predict and mitigate drug shortages; and “encour…
Article
Evaluating Design Margin, Edge of Failure and Process
It is a poor measure and is not recommended as a metric for process capability. The primary reasons Cpk should not be used are as follows:
• It only measures the worst case.
• PPM failure rate…
Article
Evolving demands of process development services
Another way timelines can be accelerated is by developing an ‘end-in-mind’ process strategy to seamlessly connect discovery, development, and commercial API needs from milligram to metric ton scale. B…