In August 2014, Xavier University and PwC led a team of 30 industry professionals to develop a framework of metrics linked to patient safety, that could be viewed during an inspection, and coming about as a response to FDA’s new steps towards allocating resources based on risk.
“On July 9 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, expanding FDA’s ability to safeguard and advance public health. The Act provides FDA with the ability to collect data and information from pharmaceutical companies prior to or in lieu of an inspection (FDASIA Title VII, Sections 704, 705 and 706). In February 2013, FDA announced its Quality Metrics Initiative, in which it engaged the pharmaceutical industry to develop a list of data FDA should request from pharmaceutical manufacturers to assess product quality risk and, therefore, aid in its risk-based resource allocation decisions.”
In July of 2015, FDA also issued a draft guidance to the industry, “Request for Quality Metrics,”stating that metrics collected by FDA would be used to help develop compliance and inspection policies and practices Improve the Agency’s ability to predict and, therefore, possibly mitigate future drug shortages
Encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.
The three main focus points of the paper now published by Xavier University and PwC's working group were to:
- Identify metrics that would enable the industry and FDA to understand proactively the risk to product quality
- Assess risk to product quality across the total product lifecycle to drive a mindset of designing quality into products at the source
- And provide a framework that could be used by FDA to assess data gathered during an inspection and therefore, within the context in which it was generated
The proposed metrics framework was designed as a tool that stakeholders across the industry could use to inform decisions and trigger action.
“It is built upon driving a mindset of continual improvement that includes feedback loops across the entire enterprise to design quality into the product proactively at the source, instead of reactively
catching inadequate quality after manufacture.”
Presentations on the paper will also take place at the upcoming PharmaLink Conference this March 15-18, Ohio and will be made available on the PharmaLink website.
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