What is Predictive Product Quality??



Background

CDER (Center for Drug Evaluation and Research) created the Office of Pharmaceutical Quality (OPQ) to ensure that the American public has access to quality medicines. By integrating all facets of pharmaceutical manufacture—inspection, assessment, policy, research, and surveillance—the OPQ seeks to strengthen pharmaceutical quality on a global scale.

Thanks to the OPQ’s creation, the FDA is now poised to promote “One Quality Voice” to spearhead uniformity across the board for all new, generic, and over-the-counter drugs. The OPQ has made it clear that they want the pharmaceutical industry to “up” its game since simple regulatory compliance has become little more than a baseline and no longer good enough to earn a passing grade from the FDA. These new efforts seek to reinvigorate the pharmaceutical manufacturing sector as a whole.

Key Points

  • The FDA has acknowledged that inspections alone are unreliable in predicting quality.

  • The unacceptably high incidence of product recall and defect reporting demonstrate deficits in process and product design, many of which can and should be rectified.

  • Contemporary metrics are insufficient in and of themselves to predict quality.

  • There is a heightened emphasis on an organization’s quality culture.

  • The FDA is asking organizations to measure their Quality Culture quantitatively and directly.

  • The OPQ wants to know what leading quality indicators are being used to measure the organization’s commitment to quality.

How PPQ Supports OPQs new Approach

  • An expert task force comprised of more than 20 industry thought leaders has identified several leading quality indicators via robust analyses including influence mapping to assess the depth of stakeholder influence.

  • These leading quality indicators are used as the basis to measure an organization's sentiment and alignment throughout every area.

  • A series of sophisticated algorithms developed by Nobel Prize winner Thomas P. Schelling are used to create “Big Data” clusters that promote creation of a mitigation road map to identify and address potential problems.

  • Each organizational level and function provides input, thus creating a truly comprehensive measurement.

  • The resulting data reveals formerly unknown risks and pre-failure knowledge and assigns quantitative values to the organization’s quality culture.

What is the Return on Investment (ROI)?

Because the PPQ model prioritizes areas that need to be addressed first and identifies functional misalignment across the organization, an action map (with timelines and tasks assignments) can be developed that clearly outlines the necessary steps to improve an organization’s quality culture.

Thus, when budgets are examined, management is better able to explain—with a high level of confidence—where the company’s money will be best spent. The resulting “Big Data” not only simplifies the entire decision-making process but also eliminates the risk of misallocating funds, thus increasing the company’s profits and ROI.

Once the baseline has been identified, a short 12 to 18 months is all it takes for management to have a clear picture of the action plan’s overall effectiveness. These steps not only save time and money and adhere to industry standards but also improve the organization’s overall quality culture.

If you have any questions about PPQ, please feel free to call Compliance Insight at 513-860-3512

Please go to our PPQ page to learn more and download Xavier Health's white paper.

https://www.compliance-insight.com/ppq

#PPQ #poorquality #FDA

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