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QbD in the United States: work hard, play hard

‘Opposites’: that’s the word that comes to mind when looking back on my four week adventure for QbD in the United States. Extreme opposites. In friendliness and helpfulness towards foreigners – people were extreme friendly or extreme rude, there was no middle way – but also in attitude towards work. Because American people know how to get things done.

Since 14 months I’m working – via QbD – at GEA, one of the largest suppliers for the food processing industry, the pharmaceutical industry and a wide range of other process industries. At their site in Wommelgem, Belgium, I’m working on validation tasks regarding their patented ConsiGma™ technology. In short, this means that I provide documented proof that their machinery functions as it’s supposed to do, following all the required rules and legislations. In case of small machines, this is easy to accomplish in house. This time however, GEA was working in a unique collaboration with Pfizer and G-CON. Together they’ve created a modular manufacturing prototype that runs continuously, and quickly delivers customized quantities of drugs. This next-generation technology rapidly and efficiently transforms drugs from powder into tablets. The advantages for pharmaceutical manufacturers: a faster time to market.

With such big projects it’s important to make sure an end product works properly as a whole. That’s why I set off to Pfizer’s Research and Development facility in Groton, Connecticut, to inspect this special project live on the site. At Pfizer, a biopharmaceutical and consumer healthcare company, my work consisted of qualifying the system. In other words, when the machinery was fully installed, my job was to provide documented proof that the machine worked properly and consistently: now and in the future. This meant a lot of work. I was playing the ‘bad ass’ operator challenging the system and trying to discover its weak points regarding product quality and eliminate them once and for all. A challenging task, considering the innovative and complex technology that’s used. An accurate estimation of all possible risks was required to prevent quality risks as much as possible.

And that’s where the American ‘getting things done’ mentality made its entrance. Although it became clear that the good old cliché about the difference between theory and practice was true, we’ve managed to fulfil the qualification almost entirely. Whether it was a holiday or weekend, we burned the midnight oil, accompanied by a little bit of stress now and then. Especially when the American Food and Drug Administration (FDA) honoured us with a visit, to get acquainted with this new technology and to investigate whether to make use of this new way of producing Oral Solid Dosages (OSDs) in the future. But fortunately the cliché that hard work pays of in the end also proved to be true, and Pfizer is ready for the next chapter in OSD processing technology. For me, this project proves that QbD holds its own, also outside the Benelux boundaries. And to recall the extreme opposites that I mentioned earlier: in 95 percent of the cases people were extreme friendly to me, and at the work floor even one 100 percent.

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