The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said an agency official, the results of which will help inform the development of a future rating program.
Michael Kopcha, director of FDA’s Office of Pharmaceutical Quality (OPQ) also told a recent webinar that the public should not confuse quality metrics with QMM. Kopcha and other officials discussed the agency’s recently concluded QMM pilot programs and its approach to QMM at a 25 May webinar sponsored by FDA’s Small Business and Industry Assistance (SBIA) program. FDA’s QMM approach was outlined in a white paper released last month.
In the white paper, FDA proposed the development of a rating system to measure a firm’s QMM as a way to mitigate drug shortages and enhance product quality, but came short of offering any specific proposals on how it would work.
During the webinar, Kopcha touted the benefits of using a maturity quality rating system to improve drug quality and reduce shortages. He also explained that the quality metrics initiative feeds into QMM.
While the white paper offers a “fairly simple” definition of QMM, it actually means something much broader. The paper defines QMM as “the state attained by having consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.”
Kopcha said, “QMM is an umbrella concept, and many things fall under it. For example, quality metrics are a key aspect of a mature quality system within pharmaceutical companies, they need these approaches for quality issues and to drive continual improvements, however QMM is about much more than these elements.”
Kopcha further stressed that QMM and quality metrics are not the same. “There’s a point that I want to emphasize. I have seen that many get this wrong in the conversation and in press articles about our QMM programs. Quality maturity ratings and quality metrics are not the same thing. They are related but they are not the same thing. I can’t stress that enough because people are assuming they mean the same thing and that one thing translates to the other. Quality metrics is one metric that informs quality management maturity ratings.”
In early March, FDA outlined a revised plan to collect quality metrics data from pharmaceutical manufacturers in efforts to revive its earlier stalled efforts to obtain manufacturing quality data to mitigate potential drugs shortages.
Kopcha said that “studies have shown that the effective use of quality metrics is one charactierics of robust site QMM.” He added that the topic of quality culture has been studied by the University of St. Gallen, the Parenteral Drug Association (PDA) and Dun & Bradstreet. These studies show that “sites with more mature PQSs are better able to anticipate and resist supply chain disruptions and drug shortages.”
He also touted the benefits of using a QMM program to measure pharmaceutical quality. “I may be biased but it seems that nearly everyone in the pharmaceutical supply chain benefit from ratings. Pharmaceutical manufacturers with a high QMM get recognition in the market, and purchasers and payers have more confidence in the supply chain, and patients and health care providers will get medicines less at risk if shortages … If we do this right, everyone comes away more confident in their next dose of medicines.”
Pilot learnings
In other areas along the QMM front, Jennifer Maguire, the director of OPQ’s Office of Quality Surveillance, said she was encouraged by the learnings from two QMM pilot programs in developing a future ratings program.
In 2020, the agency launched two pilot programs related to manufacturing quality management, one pilot program characterized the QMM for finished dose dosage forms for domestic manufacturers of prescription and OTC drug products, while another looked at QMM for active pharmaceutical ingredients (APIs), including drug substance intermediates, for foreign manufacturers.
Maguire said seven manufacturers participated in the domestic pilot, which was completed in 2021. Eight foreign manufacturers participated in the foreign pilot, which was completed in March 2022.
The domestic pilot focused on six quality management maturity improvement program areas including leadership and governance, operations, continual improvement, stakeholder engagement and satisfaction, knowledge management and workforce engagement.
The foreign pilot was conducted virtually and covered four areas: sustainability, risk management, compliance, and quality culture.
For both pilots, participants were assigned scores ranging from one to five scores, with one representing the lowest quality maturity level and five the highest score. Sites were asked to self-assess themselves using these measurements. In the final tally, all of the participants in the pilots received a score of three or above. Manufacturers at the foreign sites were able to see how they compared against their peers.
At the conclusion of the pilots, FDA came away with different learnings. The first is that “QMS assessments are not audits and they are not inspections. This does not mean the site is not nervous when assessors are on site. Making them comfortable is a bit of an art,” Maguire said.
Another learning is that assessors need to ask follow-up questions. “They were very good at asking the original assessment question, but there were missed opportunities to ask follow up questions which would take the conversation a bit deeper to really understand what was going on at the site,” she added.
There were also “missed opportunities to ask for more concrete examples, assessors also need to be trained to avoid asking questions that would require and yes or no answer and need to provide questions that would require open ended answers.”
“Assessors also have to avoid lecturing and offering an opion, such as ‘this is the best example of quality risk management that I have ever seen,” Maguire added.
For their part, some of pilot participants said some of the questions used in the assessment were “complex” and made it difficult to understand what was being asked.
“On the flip side, we did hear that the quality maturity assessments helped sites identify their strength and weaknesses. In some cases, the topic area had not been considered previously and were brought to light the first time during the QMM assements. Many of the sites found the pilot beneficial to their continual improvement program and found that it helped them reflect where they are not and where they need to go to improve,” Maguire said.
“Executing the two quality management maturity pilots really provided a great amount of insight on how we might implement the future QMM assessment protocol, and all of the stakeholder engagement that we conducted highlighted additional program considerations. Overall, I’m thrilled that the sentiment for the program is really positive,” she concluded.
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