WHO recently reported that 7 to 15 per cent of all medications in industrialised countries are falsified in some way*. In an attempt to counter this, a new EU directive has been developed, which means that all prescription medications have to be serialised – or, in other words, patients have to be able to track them. Semcon has supplied three projects to pharmaceutical company Recipharm to ensure that their production lines are compliant with the EU requirements on time.
In Sweden, most people are used to buying medicines at pharmacies or having them prescribed by doctors. This is a secure system, and many people trust it. But the fact is that falsifying and copying medications is a common problem in a number of European countries. This is why the EU has developed a new directive, the Falsified Medicines Directive (FMD), which means that all medications in Europe have to be serialised as of February 2019.
The right knowledge to cope with stringent documentation requirements
Recipharm is a pharmaceutical company operating in the field of contract manufacture. They have been working for a long time to serialise medications, and needed to adapt additional production lines to meet the EU’s new requirements on time. Semcon was chosen as they have both the technical expertise and the relevant skills relating to quality and documentation requirements in the pharmaceutical industry.
The pharmaceutical industry has extremely stringent demands as regards documentation. Semcon had the expertise relating to both this and the technology required, so they were the right choice for the contract.
A number of Semcon offices put together a custom project team for an initial project in the summer of 2017. This team was made up of project managers, mechanical, electrical and automation engineers and quality assurance officers. Their job was to make sure that production met drug manufacturing requirements in accordance with GMP, a set of international regulations relating to the production of medications.
Time-consuming and technically challenging projects
Semcon’s job was to install and commission materials management systems. These form part of a production line for serialisation of medications at the Recipharm production plant in Karlskoga. Following successful delivery of the first project, the two companies continued to work together on two more projects that were ready to begin in 2018.
Semcon has played an important part in a complex machinery that can be both time-consuming and technically challenging. Fraudsters in the pharmaceutical industry are becoming increasingly skilled at packaging their medications to make it seem as though they are labelled correctly and approved by authorities. The more difficult it is to detect these medications in time, the greater the risk when they reach end-consumers.
Fake medications can be identified in a variety of ways. One of the most common is to label the packaging with a misleading label. The fact that they contain illegal substances, incorrect quantities or poor quality is easy to overlook as a result.
When you buy something at a pharmacy, scanning the barcode should indicate that this particular pack has never been sold before. Quite simply, we are helping to prevent the sale of fake medications.
Now that the deliverables requested have been received, Recipharm is able to continue running its business as usual. In turn, their resellers and suppliers can go on selling approved, trackable medications to their patients. Semcon and Recipharm have stayed in touch so that potential projects can be implemented as and when the need arises.
Our expectations have been met by quite some margin, and we will be maintaining contact so that we can work together again in future.