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Editor's Message

PDA Letter 4.0?

One of the best parts about living in the Washington, D.C. area is being within easy reach of numerous museums covering a broad array of topics. One of my favorites is the Newseum. My favorite gallery features an 18th century Boston newspaper reporting the death of Blackbeard the pirate in heavy black text on yellowed parchment, complete with exceptionally gory illustrations—a story that was “breaking news” to the paper despite being several months old by the time of publication. Contrast this with the exhibition of the Conus 1 satellite truck, the world’s first satellite newsgathering vehicle. Developed in 1984, this truck enabled local television stations to air live news reports instead of depending on networks for coverage. Quite the juxtaposition, indeed!

I have that same feeling when I look at photos of parenteral manufacturing in the 1930s through the 1950s. In one particular photo that adorns a wall here at the PDA headquarters, rows of workers are seated next to each other—ungowned, with no barriers between them and the product. Certainly, unthinkable today.

Here’s something to think about: there would have been no data about the production process until after a batch had been produced, perhaps not even for weeks or months. That data would also have resided on paper, which we all know can be damaged, lost or even altered.

Just as we can receive real-time news updates on our mobile devices, Industry 4.0 is enabling pharmaceutical manufacturers to learn about issues in the production process in real-time. Throw in automation and other new technologies and there are exciting changes ahead. PDA’s Manufacturing Science and Operations Program (MSOPSM) team has been working to bring Industry 4.0 topics to the forefront of PDA’s membership, including the 2018 PDA Manufacturing Intelligence Workshop held in March. The many members of the MSOP I have met are all passionate about transforming current manufacturing processes for the better.

In previous columns, I have covered how the PDA Letter is following similar trends. I want to use this opportunity to remind readers that the Letter editorial team also publishes “digital exclusives” on our website that do not appear in print editions. Recent digital exclusive articles include a two-part summary of the 2018 PDA Europe Pharmacopoeia Conference (“Industry Converges on Pharmacopeial Convergence” and “A Deep Dive into Pharmacopeial Harmonization”), a look at how rapid monitoring and QRM can improve environmental monitoring (“Does QRM + RMM = Better EM?”) and a case study on cryopreservation (“Evaluating CellViability After Cryopreservation”). Along with these articles, two recent “On the Issue” videos have spotlighted U.S. FDA regulators ( Dan Mellon, “Packaging Components: Extractable/Leachable Control,” and Francis Godwin, “Heparin Crisis: 10Years Later”).

Industry 4.0 will continue to be a topic discussed in the Letter and at PDA conferences around the world. Speaking of which, if you attend any PDA meetings in the D.C. area and have some extra time outside the meeting, I encourage you to visit some of our local museums, especially the Newseum.