Guest blog written by Walter Morris, Director of Publishing, Parenteral Drug Association, on behalf of the PDA Quality Metrics Task Force
The US FDA Center for Drug Evaluation and Research (CDER) reached out earlier this year to industry and the public for input into plans to implement parts of the 2012 Food Drug Administration Safety and Innovation Act (FDASIA).1 Quality manufacturing leaders in the industry must now seize this opportunity to help bring about real changes to a system of regulatory inspection and enforcement that, in spite of reasonable attempts at reform over the last decade, is struggling with new challenges. Continued high-cost enforcement actions, plant closures, drug shortages and, regrettably, real harm to patients have pushed everyone involved with this industry to recognize, finally, that a new regulatory and quality paradigm is needed.
FDASIA is the potential game-changer. Section 705 of the Act requires FDA to implement a risk-based inspection regime. FDA has been moving in that direction anyway, but with it now codified, the agency must reorient its inspection program to comply with the law. Section 706 of the Act allows FDA to request, and firms to provide, records in advance of or in lieu of inspections.
Neither 705 nor 706 provide any kind of detail on implementation, and FDA is reaching out to industry to help fill in the details before they issue formal guidance. CDER officials are exploring Quality Metrics as records they would request and needs help defining what Quality Metrics should be used as inputs into an Inspectional Risk Model, which helps determine inspection frequency.
PDA supports this endeavor and has launched an initiative to draft a “Points to Consider” (PtC) report to share with FDA. The PtC will express PDA’s general support for the use of Quality Metrics in the FDA Inspectional Risk Model, with some caveats. There exists no single set of metrics that can act as a surrogate to reliably predict quality or compliance across different sites, products, and companies. Secondly, use of Quality Metrics will create even more challenges for industry.
PDA, however, recognizes the many benefits of metrics. These include potentially enhancing visibility/transparency between industry and regulatory, prioritizing and focusing on the most important issues, elevating (finally) an organization’s focus on quality and driving continuous improvement.
For these reasons, PDA’s “Points to Consider” paper on Quality Metrics will discuss the importance of both manufacturing quality performance metrics that can be used in FDA’s Inspectional Risk Model, and continuous improvement metrics that industry should embrace to ensure continuous improvement of quality internally.
Both types of metrics present challenges to define. Manufacturing quality performance metrics will be grounded in GMPs, with few shared definitions across the industry. Still, PDA believes that many commonalities can be fleshed out as objective metrics. For instance, the PDA task force has already identified several groupings of common metrics with respect to manufacturing quality performance for products and sites. These should be quantitative and focus on GMP requirements that would be discussed during a GMP inspection.
Continuous Improvement Metrics, on the other hand, might offer the best path forward to real improvements in manufacturing quality, but they will be more subjective and much harder to define and measure across the industry.
To help PDA provide the FDA with a meaningful and impactful PtC report, the Association is inviting industry leaders and regulators to participate in its upcoming Pharmaceutical Quality Metrics Conference, December 9–10, which will be co-chaired by FDA officials and include strong participation from FDA personnel. Discussion of Product Quality Metrics, Site Quality Metrics, Continuous Improvement Metrics, and Comparing Metric Outcomes will occur in four interactive sessions.
For more information, go to www.pda.org/metrics2013.
1. Department of Health and Human Services, Food and Drug Administration. Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments; Federal Register, 2013, 78(29), 9928-9929. www.gpo.gov.