Many manufacturers and contract packagers had to learn it the hard way: serialisation is much more than just placing serial numbers on pharmaceutical packaging. During the FMD implementation rush, some companies relied on quick solutions. However, quick fixes did not live up to what they promised and gave manufacturers manifold reasons for disappointment, from lack of interoperability and compliance issues to high operational complexity, to name just a few.

As the EU Falsified Medicines Directive deadline was looming, many pharmaceutical companies, especially small and medium-sized, were struggling to fulfil regulatory requirements on time. Many saw just the tip of the iceberg and underestimated the project’s scope and complexity. Finding themselves under time pressure, many pharmaceutical companies were left with no other choice but to look for quick solutions that promised trouble-free serialisation and regulatory compliance in the short term.

Fast forward to one and a half years after the deadline, and many of those companies are still struggling. The quick fixes are now causing prolonged line downtimes and more manual work and rework, increasing total production costs and resulting in lower profit margins. As a consequence, many companies are wondering whether it is too late to change the technology. The answer from WIPOTEC-OCS: Now is the right time to change the approach and even the underperforming serialisation equipment. Since pharmaceutical companies are now already compliant, time pressure is no longer the key driver for their decisions and choices.

Video: Traceable Quality System

With its Traceable Quality System, WIPOTEC-OCS supports pharmaceutical manufacturers in achieving compliance with serialisation and Track & Trace regulations in the EU and many different countries worldwide. The company has developed a broad range of high-quality serialisation and aggregation solutions that, due to their modular design, can be highly customised to any application requirements. Pharmaceutical manufacturers and packagers worldwide appreciate these solutions for their flexibility, high-level interoperability and standardised interfaces.

One of the key advantages of the TQS is that the solutions are modular, scalable and interconnected. This gives companies great flexibility to add or remove application-specific modules without disrupting communication within the serialisation system or with other machines and the site system.

“The cooperation with WIPOTEC-OCS is an important strategic decision given the maximum flexibility we are striving for.” – Dr Marco Klingele, Head of Administration and Track & Trace Programme Lead at Losan Pharma.

Standardised interfaces make TQS solutions site-system agnostic, allowing them to connect to almost any site-level data management system. This modular design increases the total lifespan of the solution while reducing maintenance costs and relieving concerns about machine redundancy. One of TQS’s highlights is its operational efficiency, which enables simultaneous configuration of the printer and cameras, and so lightens the operator’s workload. But as the saying goes, it is better to see once than hear a hundred times. Explore the technology highlights in the company's virtual innovation centre.

Forward-thinking pharmaceutical companies that have already equipped their lines with serialisation technology can even trace the movement of their products in the supply chain by deploying aggregation. Enhanced product traceability enabled through aggregation helps companies prevent product diversion by automating data exchange between the manufacturer and their trade partners. Especially in times of crisis, such as the current COVID-19 pandemic, aggregation is more relevant than ever. Reliable distribution of pharmaceuticals depends on supply chain transparency and automated data flows. Additionally, aggregation improves the decommissioning of shipping cases and pallets, as well as facilitating efficient product recalls or returns. What is more, aggregation is an integral part of a go-to-market strategy for manufacturers who intend to export pharmaceuticals to countries requiring track and trace, for example, Russia, Turkey, the US or China.