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FDA Announces Two Initiatives to Modernize Drug Quality Programs

Quality Metrics Will Provide Feedback to Manufacturers

The FDA has announced two new voluntary programs—the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program—in response to stakeholder requests for continued information and feedback on quality metrics, and to provide methods for industry to engage and inform the FDA’s use of them in the future. According to Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), and Michael Kopcha, Director of the Office of Pharmaceutical Quality at CDER, the programs will also help drug manufacturers to gain a better understanding of how quality metrics are a common feature of quality culture, and support improvements in product and process quality.

Feedback from early adopters and manufacturers who implemented quality metrics programs to address manufacturing problems indicates that a manufacturer’s overall quality program benefits from the use of quality metrics. Quality metrics, such as data on the rate at which manufactured lots have been rejected for failing to meet established standards, can help manufacturers monitor quality control systems and drive continuous improvement efforts and can also help the FDA better assess risk when scheduling inspections. This has the potential to decrease the frequency of surveillance inspections for lower-risk establishments and to narrow the focus of on-site inspections conducted.

The proximal causes of many drug shortages are quality issues such as substandard manufacturing facilities or processes. Quality metrics can be useful in identifying situations in which a drug supply disruption may occur; metrics can help mitigate potential future drug shortages. This will help to reassure patients that quality medicines will be available when they need them.

The Quality Metrics Feedback Program solicits information from drug manufacturers and sponsors that have implemented and are currently using quality metrics programs.

The purpose of the Quality Metrics Site Visit Program is to provide on-site, firsthand learning opportunities to the FDA staff involved in the development of the FDA Quality Metrics Program. The Site Visit Program also is intended to provide stakeholders with the opportunity to explain the advantages and challenges they’ve experienced when implementing and managing their quality metrics programs.

Source: blogs.fda.gov, July 26, 2018

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