As a pharmaceutical project engineer at QbD, every day is different. Even more so when you visit a country very different from ours. Last month, I went to Japan to visit Mitsubishi Tanabe Pharma Company (MTPC), where we are running a Good Distribution Practices (GDP) project with one of our partners. MTPC has several European clients and the company needs to comply with European GDP standards – since there aren’t any Japanese GDP standards yet. I visited MTPC to discuss GDP standards with the company, to take a look at their documentation regarding the standard and to make an inventory of the requirements the company needs to comply with GDP standards. A gap analysis, in other words.
My trip to Japan proved why it’s important for a pharmaceutical project engineer to visit companies, instead of simply talking to them via e-mail or telephone. Thanks to my trip, I now understand perfectly why our Japanese colleagues had some difficulties understanding the principle of loading docks for trucks, for example. Since trucks in Japan open via both sides – instead of via the back, like in Europe – they don’t use a loading dock to load and unload vehicles. Instead, trucks drive into a factory or warehouse. Another example is the fact that we’ve talked about sealing and tamper proofing a lot, but things became far more clear when we saw the Japanese packaging in the warehouse with our own eyes. In short, only by seeing the warehouses in real life, we were able to thoroughly analyse their activities and provide advice on the company’s compliancy.
In addition to seeing activities with your own eyes, it’s also important to visit companies in order to realise things (like automation) in other countries differ from Belgium. In Belgium, many pharmaceutical companies benefit from automating their production environments. Japanese companies, on the other hand, are less aware of the advantages of automation of logistics, for example. Order picking, stock management, temperature control: everything is in place to have it automated, but in Japan, they don’t seem to trust the automation. An example: besides the electronic system, a man comes in twice a day to manually measure the warehouse temperature using a thermometer. Based on those measurements, the HVAC system is adjusted…
Although some (automation) processes in Japan seem a bit contradictory to us Europeans, the country indeed proves it has great knowledge of automation. Seconds before an earthquake, I automatically received a mobile message – in Dutch! – with an earthquake alarm. Well, that’s what I call automation!