In addition to the FDA Quality Metrics Site Visit Program discussed in Part 1 of this article, the agency also has a Quality Metrics Feedback Program, which aims to obtain more information about quality metrics used within the industry.
FDA is interested in understanding the quality metrics that are most meaningful for companies and particular product(s). This includes the definitions of those metrics, quality metrics data for specific products, (historical and current), management of the quality metrics program, and the company’s approach to assessing quality culture.
At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, Procter & Gamble Quality Leader and Leadership Coach Steve Greer shared his company’s experience in the Feedback Program.
“To give you a quick overview, the difference between the site visit and the feedback program is that with the feedback program we are actually going to submit real data to FDA on our products and site performance,” he explained.
What Quality Metrics Are Sought?
FDA asked P&G for the three quality metrics included in the Draft Guidance for Industry on Submission of Quality Metrics Data: lot acceptance rates invalidated out-of-specification rate, and product quality complaint rate. Once P&G submits the data, they plan to hold a series of discussions with the agency about the data.
“They will take our information and analyze it through the models that they have built, and then we will sit down and have conversations around the meaning behind that information,” Greer said. For example, does the agency’s analysis indicate that there is a site or product that looks like it could be having issues?
Some of the other topics that FDA is interested in are listed in Figure 1. Included are incentives, the use of which has been an ongoing conversation.
Figure 1 The FDA Quality Metrics Feedback Program
“What are appropriate incentives in a voluntary quality metrics program? What would we like? To voluntarily report your data to FDA, what incentives would be helpful for you?” Greer asked the audience. Audience members proposed less frequent and/or preannounced inspections as incentives. Below are Greer’s comments on each.
Less frequent inspections
“There can be a downside to fewer inspections. We were talking about this over lunch. I know what I am about to mention is theoretical—it has not happened at your company. But when FDA comes in and gives you a citation or an observation, sometimes it gets a little bit easier to get your finance manager to write a check. I know that has not happened to any of us in here, but I have heard that that could be the case. So, if we have less frequent inspections, that might make it a little harder sometimes to get some of the support we need. But that is one of the most frequent answers to what industry would like.”
“This would be like a foreign inspection. It lets the company have the opportunity to get the right people on site and the right resources rather than showing up unannounced.”
Greer added that for people with over-the-counter (OTC) drug products, an incentive would be pushing monograph reform through Congress, “which will definitely help speed up innovation in the OTC space. And what about faster approval of innovation? Could that be an incentive that would have business benefit?”
[Editor’s Note: Three weeks after Greer delivered his presentation, on March 27, 2020, the monograph reform bill he was referring to—the bipartisan S.2740 Over-the-Counter Monograph Safety, Innovation, and Reform Act—passed as part of the sweeping Coronavirus Aid, Relief, and Economic Security Act, which President Donald Trump signed later that day. The measure represents the first significant update to federal oversight for OTC products since 1972.]
“These will be the things we will have the opportunity to sit down and talk with FDA about. So, I am excited about it, even though it is work to get ready for it and a little bit scary to submit our data. But FDA has promised that they are not going to come knocking on our door just because we submit data and they have a question. We will actually sit down and have a conversation.”
There can be a downside to fewer inspections
Measuring Quality Culture Maturity
Greer responded rhetorically, “does quality metrics have a life or not, as a mandatory reporting program or as a voluntary reporting program? I do not know. Personally, I think it probably will have a life. But the conversation right now has really shifted from quality metrics to quality maturity.”
He noted that the quality maturity program grew in part from the agency’s work on drug shortages. FDA’s Drug Shortage Task Force recommended a voluntary rating system of a site’s quality maturity that firms could share with customers.
Also at the Georgia GMP Conference, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented the following slide depicting the quality maturity program Greer referred to (Figure 2).
Figure 2 Quality Culture Maturity Indicators
Is Your Facility an A+ Site?
Greer discussed the possibility of FDA grading facilities and what that might mean.
While the agency has indicated that it would not make the grades publicly available, “to be quite honest, whether FDA chooses to grade us and make those grades available, I think it is just a matter of time because of the pressure for transparency. We see that every day—consumers demanding more and more information about our products and about our supply chains.”
The conversation right now has really shifted from quality metrics to quality maturity
For example, he said, P&G has programs in place using blockchain in which it is looking at the farmers and the farms where cotton is grown that makes its way into Tampax tampons—all the way from the farm to the final product. “That is the level of information consumers want more and more, and they are demanding it,” Greer explained.
“I think it is only a matter of time before they are going to quit having patience for the fact that they go to a store and purchase a drug and they really know nothing about that drug and the quality behind that drug. I think this is one, whether we like it or not, that is eventually going to become part of life. My encouragement to us is to partner with FDA and create a program that has meaning and that adds value both to us as well to our consumers and patients.”
He also pointed to the Case for Quality program in the device world that began in 2011. According to the agency, “the Case for Quality program is intended to help the FDA identify device manufacturers that consistently produce high-quality devices. It will allow FDA to identify participants with manufacturing practices that are of consistently high quality that also align with the laws and regulations implemented by FDA. Finally, the program is designed to identify successful manufacturing practices to help other device manufacturers raise their manufacturing quality level.”
In Part III, Steve Greer provides a compelling, true story about a SCUBA diving incident and uses the lessons learned as an analogy for how to ensure that pharma quality systems function properly.
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