Setting meaningful specifications in the pharma industry

JULIA O'NEILL: One of the issues that plagues pharmaceutical manufacturing and one of my passions is that it's typical in pharmaceuticals to set specifications based on process experience.

When we do that, and then we do a process capability assessment, we're making a circular calculation. We set control limits or specifications based on what has been produced so far. We produce some more, and then compare those results to what was produced in that initial baseline period. And we usually get a number close to one, which is exactly what we'd expect to get, and it's not very helpful.

We really need to do better at setting specifications, and with all these advances in genomics and real-world evidence, I think we are on the verge of setting specifications that are more relevant to the patient. There's a lot of work underway. The FDA has come out with a number of initiatives supporting that shift. We still have a lot of work to do, but that is coming.

I do hear people, even within the pharmaceutical industry, moaning about, well, why can't we be Six Sigma? Until we set meaningful specifications, we're never going to be Six Sigma, because we're going to end up right about one.

ANNE MILLEY: How interesting. That sounds really important.

JULIA O'NEILL: Very important. I feel very strongly about that, and as I'm working with novel biopharmaceuticals, I keep pushing people. The scientists understand so much more about the products, the mechanism of actions. A product that was developed 40 years ago, we didn't have all that knowledge. Now we do, so we need to start building it into specifications. We also need to make sure regulators are comfortable with that, because it's a big change in how things are done.

ANNE MILLEY: Right. Wow, well, keep making progress on that. That sounds like that's really important to make progress on.

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