With only a few weeks of planning, PDA’s Quality Systems Interest Group pulled off a successful session on quality metrics Sept. 24 at the 2018 PDA/FDA Joint Regulatory Conference.

Despite having been listed on the conference agenda for a mere three weeks, the room was packed. Attendees came to listen to Steven Mendivil, Senior Advisor, International Quality External Affairs, and leader of PDA’s quality metrics task force, share a dialogue on quality metrics with Tara Gooen Bizjak, Senior Science Policy Advisor, Pharmaceutical Quality, CDER, U.S. FDA.

Below is a sampling of the discussion:

Mendivil: This is the first time that I have seen a second, and possibly even, a third draft guidance. Can you speak to some of the challenges FDA has experienced in this journey?

Bizjak: This has been quite a big effort—almost unprecedented in my experience… everybody has their own opinion, right? Just like in FDA. And just like with stakeholders in either industry or academia as well. So, I think there have been challenges but there are also opportunities. This is a really large opportunity for the pharma industry to really take that next step forward encouraging more modern quality systems and more modern manufacturing as well as an opportunity for FDA to learn from some of that information and be able to really make a…change in our regulatory oversight.

Right First Time

Mendivil: I think when it came to the points about a “common definition,” there was a sense that these might not be the most valuable metrics such as “right first time” metrics, which sounds conceptually great, but there is no common definition of what it is.

Bizjak: In fact, in the first Federal Register, notice we did not include right first time because of so many variable definitions for the concept of right first time and this internal evaluation process…we asked if right first time was a valuable metric to include and we did not receive a lot of feedback about that.

Recent Activity

Mendivil: Can you explain more about the two Federal Register notices that were published over the summer? One detailed how companies could arrange in-person meetings at FDA headquarters and the other covered how companies can request an FDA site visit.

Bizjak: There are two Federal Register notices. One is what we refer to as the feedback program and the other is the site visit program. The site visit program is fairly straightforward because everyone here is used to site visits—the concept of having FDA come out and visit the site, not issue a warning letter, not issue a 483, just to learn about the site. That is a more tangible process. It would be a one-time visit.

And, then, the second one is more of an in-depth opportunity to provide feedback and back-and-forth dialogue. We set this up using the meetings approach, like the Type C meetings and pre-IND meetings, as a mechanism to be able to have this dialogue. A company would provide information about metrics they feel are appropriate, definitions that work for them that they want to share with us and have that back-and-forth communication where a company could present, “This is what we do. This is how we run our quality metrics program, how we have adapted over time.” That sort of thing… they [the meetings] can be done virtually, too. This just has an opportunity for follow-up and more discussion.

Audience Question: Are both of these open to anyone?

Bizjak: That is correct. All the mechanisms are open to anyone who is applicable… it is open to everyone [barring Agency prioritization needs for site visits].