FDA’s new draft guidance on quality metrics bears clear witness to the iterative and organic nature of the agency’s initiative and the role industry has been playing, and will be expected to play, in helping assure that the intended goals are achieved.
The draft stands out from other of FDA’s guidances in the compliance field in that it focuses as much on highlighting the issues that need further consideration, dialogue and resolution as it does giving directions on current expectations and procedures. The agency is transparent on where the uncertainties and gaps lie to date and further industry input is especially important and sought.
The first of the two stories in our metrics coverage in this issue focuses more directly on the FDA draft guidance and the substantive notice that accompanied its release. It begins with a look at the quality culture component of the metrics equation, and the ongoing efforts by PDA and ISPE to help understand how culture can be assessed and advanced to support improved industry quality practices and regulatory policies. The story then explores what FDA has put on the table and is now looking for from industry to help the metrics initiative play its part in improving inspection policies, reducing drug shortages, and encouraging better quality management systems and manufacturing innovation.
The second story in the July/August issue takes a look at the arc of ISPE’s effort to help FDA by benchmarking on current industry metrics practices and conducting a pilot to explore the issues confronting the agency in determining what metrics would actually be viable to include in a reporting program. A substantial 100-page report emerged in June from “Wave I” of the ISPE pilot effort, and “Wave 2” is now underway to further explore metric relationships along with data gathering and evaluation approaches that are fit for purpose.
The September Monthly Update will include a full review of the results of a meeting FDA held at its headquarters in late August to elicit further input from stakeholders. PDA, ISPE, PhRMA, GHPA, CHPA and IPEC are among those organizations that engaged with CDER officials there in the dialogue.
The third story in IPQ’s July/August issue takes a look at a compelling presentation by BMS’ manufacturing exec Ricardo Zayas on the importance of the excipient supplier/user relationship to the “speed-to-launch” imperative now driving pharma. Zayaz explained the increasing role excipients are playing in product development and quality and to the financial health of pharma firms.
With relevance to the FDA/industry dialogue around the agency’s metrics initiative, the BMS exec explained why he views “right first time” as the single most important metric in managing a pharmaceutical manufacturing facility and how excipient reliability is integral. Inherent variability in the process causes deviation investigations and leads to “all the re’s: rejects, reworks, reprocessing, retesting, reinspections, repackaging,” which result in backorders, recalls, major expenses and lost revenue. In turn, “a big enabler” to controlling variability in a process is communicating with the excipient suppliers and deploying the right excipient technology, he stressed.
Zayas’ remarks are also highly relevant to the concerns that IPEC-Americas and the IQ consortium have been expressing around the regulatory constraints to deployment of the new and coprocessed excipients that are needed to facilitate the development of the more complex, powerful and patient-friendly pharmaceutical products on the horizon. The second part of the story explains how IPEC is making its case for a more viable regulatory pathway and related inactive ingredient database improvements in the context of the user fee reauthorization discussions now going on for PDUFA and GDUFA.
The July/August issue includes over three dozen “Updates in Brief” on key developments that occurred during the summer, with links to all the documents referenced and to IPQ’s related in-depth coverage. FDA warning letters and recalls posted during the July/August period are also listed, with links to the full agency postings.
To download the July/August Issue, click here.