How to manage the serialisation challenge of anti-counterfeit regulations?04/10/2016 - John Nuyens, Pharmaceutical Project engineer at Quality by Design
Did you know falsified medicines are a serious threat to patients all over the world? Fortunately there are various anti-counterfeiting methods in the supply chain of pharmaceutical products, such as serialisation technology and track & trace technology. Serialisation technology provides unique serial numbers for each sales pack. This way, you ensure that genuine medicines can be distinguished from counterfeited ones. A track & trace technology keeps track of where products are or have been and who was responsible for them at a certain point in time.
To help the pharmaceutical industry acquire a clearer picture of how to set up serialisation and track and trace systems, and provide them with an overview of current and upcoming legal requirements regarding anti-counterfeit regulations, QbD and BlueCrux organised a serialisation and track & trace event. On September 29, about twenty attendees in the healthcare and life sciences industry gathered at the BlueCrux office in Mechelen, Belgium to discover all the ins and outs of serialisation and track & trace.
To make sure people were able to attend the seminar, we started early at 07:00 AM. After the opening and a nice breakfast, BlueCrux started with a talk on the key operational supply chain challenges facing anti-counterfeit regulations. Next, attendees were able to learn from healthcare and pharmaceutical expert Johnson & Johnson about how to manage serialisation in the complexity of pharma. A real eye opener for me. Normally, I’m involved in the technical process of packing up products in a serialised way. It was interesting to hear more about the steps after this process, for example in the distribution centers. It was great to see the enthusiastic audience discuss the various topics and share their knowledge. After all, this was an important goal of the seminar.
After the break, I told the attendees about validation and how to maintain the validated state in the world of serialisation. Next our client and Alcon talked about how Alcon Puurs and Novartis worked out a standardised approach for the serialisation of complex products. One important challenge in serialisation is the vast of amount of different legislations. There’s a lack of real standards for serialisation and there are too much differences in European, American, Chinese or other legislations. Alcon explained how they solved this problem, by retrofitting their packaging lines so that they are compliant with multiple legislations.
I look back on an interesting, interactive seminar where we provided attendees with a broader view on the impact and advantages of serialisation and track & trace technologies. Want to know more about these subjects? Attend our half day Serialisation and Track & Trace training or contact us!