Last week’s event and conference provided a great opportunity for those engaged in the manufacturing segment of the pharma industry to come together and share best practice. It was good for us to be there too. The opportunity to listen to what others are saying across the industry keeps us here at Kallik appraised of what’s foremost in the minds of our customers.
It wasn’t surprising that regulatory related topics featured strongly in discussions at what was an interesting and informative event last week. Both the impact of Brexit and Serialisation are clearly hot topics across the industry. Unsurprisingly so, as taken separately they both create major challenges and uncertainties for the industry. Taken together, some might be wondering whether life couldn’t get any harder. With the UK planning to leave the EU two months after the FMD comes into force in February 2019, the whole of the pharma supply chain right from regulatory affairs to contract manufacturing in packaging has some work to do to ensure continued compliance
Two things are for certain however – Brexit will happen and so will the EU FMD. Neither of these is going to go away, so if we’ve not yet started thinking about how to respond, we need to get started very soon. If we leave it much longer, there is a risk that the plethora of point solutions associated with managing regulatory driven content, labelling and artwork creation and packing and print production will increase to the point that it becomes economically unsustainable.
So where does labelling and artwork fit into the big picture here? Well, the first consideration is that having multiple systems and processes hosting labelling content used for regulatory submissions, artwork creation and serialisation data is most likely to be inefficient and prone to error. The second point is that it is very hard to prove compliance when you have to extract and collate information from multiple systems and consolidate this into a single audit report. Thirdly, why choose a discrete physical solution for integrating variable manufacturing data with core labelling content when you can do this up in the cloud electronically?
Here at Kallik, you might have heard us talk about taking a connected approach to artwork and labelling. With Brexit and Serialisation looming on the horizon, embracing both these as an opportunity to create a more open, flexible and sustainable approach promises an easier future for all.