Serialisation is here to stay

Although there is a growing global trend among major pharmaceutical companies to introduce serialisation production line equipment, I would estimate, based on Mettler Toledo’s experience, that less than 10% of pharmaceutical product lines currently have serialisation capability, as many companies are still waiting for legislation and regulations to be finalised. Unfortunately, implementing a global serialisation standard will be very difficult with so many countries using different serialisation standards. According to our research, at present there are 17 countries using GS1 coding, 10 countries using EAN 13 coding and 6 countries using EAN coding. In the EU, however, EFPIA is trying to harmonise coding using Data Matrix.

Frank Borrmann. Senior Serialisation Solution Project Manager at Mettler Toledo Garvens.

In contrast to many other anti‑counterfeiting methods, serialisation is all about unique data rather than unique packaging so there is no need to use counterfeit-proof packaging and markings, such as holograms. The actual serialisation of the product is quite simple and inexpensive once the correct equipment has been integrated into the production line, although procedures and systems will need to be put in place to control the data. Despite this, I believe that serialisation is here to stay because there is no better way to protect products that are vulnerable to counterfeiting. Serialisation enables products to be reliably tracked throughout the supply chain, from the production of raw materials right down to the dispensing pharmacy. Anyone receiving a shipment of serialised medicines has access to a central database and can instantly see a digital fingerprint showing the complete history of the product. This will make the production and supply of medicines totally transparent for all pharmaceutical suppliers and government agencies, and such a high level of drug traceability will make it very difficult for counterfeit medicines to be introduced into the system.

The disadvantages of serialisation are the complexity of the supply chain and the enormous amount of data that is produced; database administration structures and read and write access rights to the data all need to be finalised before a serialisation process can be effective. Another challenge is that serialisation introduces a new production line process, which may lead to reductions in line availability and performance, as well as an increase in the false rejects of good products. However, these issues can be mitigated simply by choosing the right equipment. Ideally, the chosen system should be able to cope with high-speed packaging lines and should be capable of holding the package perfectly stable and correctly positioned so that it can be marked and verified, which will help ensure that line availability and performance are not affected. Unfortunately, the introduction of a serialisation process normally causes an increase of false rejects, but a good system should be able to ensure this is no more than 0.02%.

Implementing serialisation solutions

Each pharmaceutical company will have their own serialisation requirements, which means each project will have its own special challenges. In general, however, pharmaceutical companies usually look for standard solutions that are flexible enough to be easily tailored to local regulations and production line conditions. As mentioned above, systems capable of precise and accurate product handling are also important, but the pharma company should give the solution provider as much information as possible to ensure the solution meets its needs.

Unfortunately, it is no great challenge for a good counterfeiter to copy a package and any serialisation marking that is present. This is why traceability is the key. Legislation will require that each person in the supply chain who handles the product to update the data and record when and from whom the product was received, and when and to whom the product was sent. To tell whether a product was counterfeit or not, you could request the tracking information for the serial number, which would show the complete history of the package. If you received the product from anyone other than the last person who entered in the data, the product is counterfeit. The manufacturer will be able to see all of the data. However, this may not be the case for all other supply chain members (including consumers).

Because serialisation enhances the traceability of the supply chain, it will have a drastic effect on the number of counterfeit products on the market; however, it is far too early to fully see this at present and we will have to wait a few years to see noticeable reductions. I also believe that serialisation will not stop with pharmaceutical products and that within the next 5 years we will see other industries, such as the food and tobacco industries, become subject to serialisation regulations and laws.