As members of ISPE, we are fortunate to have leaders who had the foresight to sponsor Quality Metrics Pilot programs which continue to provide a rich framework for objective data-driven discussions. One such discussion took place on 1 August 2017 when a group of ISPE members and staff met with several members of the FDA Quality Metrics team at the agency’s White Oak campus offices in Silver Spring, Maryland.
Accompanying me were ISPE Director of Regulatory Operations Carol Winfield and members from ISPE's Quality Metrics team: Steve Greer, Corporate QA External Engagement Leader, Procter & Gamble; Betsey Fritschel, Director, Quality and Compliance, J & J Enterprise Regulatory Compliance; Lorraine McClain, Senior Director, Quality Risk Management, Teva Pharmaceuticals; and Bryan Winship, Senior Director Global Quality Risk Management, Mylan.
The FDA shared their disappointment at the nature and extent of industry comments on the revised “Submission of Quality Metrics Draft Guidance” it proposed in November 2016.* This had also been highlighted during the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference in June, where FDA representatives addressed the topic during the conference's regulatory town hall.
Our meeting was an opportunity for an open and informative exchange, with both teams sharing insights and experiences.
During the meeting, the FDA team confirmed its plans to progress a quality metrics data-driven surveillance program to achieve the goals published in its draft guidance: quality oversight, continual improvement, informing risk-based inspection scheduling, including more efficient inspections by focusing on products of higher risk, and the potential for indication of drug shortages. The FDA explained why the feedback was unanticipated and the ISPE team provided context and deeper explanation on identified concerns. We also elaborated on the ISPE recommendations contained in the response to the docket, which included the development of a carefully structured pilot that would allow us to start small, learn, and evolve, as well as consideration of alternative programs. The agency also expressed strong appreciation in the value of and learnings from the ISPE Quality Metrics Pilot Program.
The meeting had a very collaborative tone, produced a highly engaged discussion, and there was a mutually expressed desire to continue dialogue within the boundaries of FDA’s Good Guidance Practices.
This is yet another example of the sharing of knowledge we hold dear at ISPE, not just among ourselves, but with the agencies and organizations with which we interact.
By: Mairead Goetz
Global Quality Head Analytical Science
QC & OpEx
Chair, ISPE Quality Metrics Team
*Public comment period ended 27 March 2017