Reliable serialization and labeling systems for manufacturers of pharmaceutical products enable to minimize the risk of counterfeiting and increase product safety. Moreover, it enables to monitor the entire supply chain, allowing to track where products have been produced and follow their shipment. Tracking and tracing technologies were designed to fight against the market of counterfeit and fake drugs. Now, they are also used in industries other than pharma. Technology and flexibility are the drivers that move traceability equipment forward. These technologies are experiencing a further leap forward due to the COVID-19 pandemic.
The numbers of the fraud market: tighter regulations in Europe and the US
According to the latest European Union report, the global total value of fake pharmaceuticals amounts to approximately 4.4 billion. Both the EU and the US, which, together, make up the majority of the global drug market, have issued regulations to fight against counterfeiting. The US specifically, through the FDA (Food and Drug Administration), has enacted the DSCSA (Drug Supply Chain Security Act). The EU has issued the Falsified Medicines Directive for the same purpose. The US appears to be the country that suffers the most, with 38% of its pharmaceutical companies hit by infringement of their intellectual property rights. The massive distribution of anti-COVID-19 vaccines that we have seen in the last few months has simultaneously intensified the phenomenon of fake drugs. The main weapon against it consists in implementing effective track-and-trace systems. The technologies for the serialization and traceability of pharmaceuticals are important against counterfeit pharmaceuticals. Furthermore, they are an asset that ensures product quality.
Track and Trace: why is it so important?
First, serialization technologies ensure quality by detecting production errors and defects, minimizing them, and rejecting non-compliant products in a timely manner. Second, effective traceability systems contribute to improving production control by ensuring constant monitoring, evaluating, and optimizing. Serialization technologies, moreover, lead to efficient supply chain management. As serialized data help operators to quickly identify at which stage of the supply chain a recalled product is and efficiently remove it before it reaches patients. Finally, Track and Trace plays a significant role in fostering protection against counterfeiting: fake products not only have an impact on the profits of pharma companies. They may also bear serious consequences on consumers’ health.
Technology trends: the point of view of pharma companies
In the pharmaceutical industry, the main necessity is to provide technologies to track drugs regardless of their different packaging methods. Examples are capsules, pallets, blisters, vials, etc. Flexibility is the key, that is why it is essential to provide both integrated and standalone solutions. Integrated solutions need to be embedded in a complete system, such as process machines or complete packaging lines. The standalone solutions need to be added to pre-existing units or lines. Miniaturization is also one of the emerging needs. Not so much in terms of system layout/size, but rather of being able to operate in the micro field. One of the most advanced systems can even print 2D codes directly on primary packaging like vials or syringes.
Not only pharma: serialization has an increasing necessity also in the food industry
Track-and-trace technology is applied also in other industries, such as the cosmetic, nutraceutical, and food sectors. The cause of this development lies in incidents that have drawn attention to safety issues. An important field of application is the early life nutrition market. An example is the serious case of Chinese milk of 2008, a scandal involving milk and infant formula, along with other food substances and components. These were being adulterated with melamine. Melamine is a very dangerous chemical that is sometimes illegally added to food products in order to fake a higher protein content.
The response to these issues is exemplified by projects such as “Track and Connect”, which Danone, one of the leading food companies, launched. The solution combines several technologies, which aim to offer consumers and retailers greater transparency on the farm-to-fork journey of the company’s infant formula. The service is based on two unique QR codes. One outside the packaging which can be scanned any time before the purchase, and one inside. The QR codes are printed in-house and laser marked on the infant formula packaging in the production facilities.
How to achieve safety and efficiency: partner with serialization experts
Together with our partners, we deliver reliable solutions in serialization. FlexLink’s focus lies in automated production flow solutions that increase the efficiency of pharmaceutical manufacturing plants and production lines. Together with our partners, we have gained extensive experience in several serialization projects. The focus of these projects was the implementation of track-and-trace systems in the consumer goods sector. The projects were carried out for various global companies in the pharmaceutical and food sectors.
To provide holistic solutions, we collaborate closely with OEM manufacturers to develop native solutions for traceability and serialization. At the same time, being part of the Coesia Group and having developed competencies in over 40 years in the business allow the company to provide tailor-made solutions for pre-existing lines and lead complete serialization projects.
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