Keep it real – serialisation and traceability

3 April 2017



How do you apply an all-round data management system that is able to track and trace throughout a product’s supply chain? Marcel de Grutter, project manager for serialisation and regulatory, and government liaison in the Established Pharmaceutical Division at Abbott Laboratories, talks to World Pharmaceutical Frontiers about how serialisation and traceability across multiple partners and systems can be implemented.


Knowing the nature of a problem is one thing, but actually solving it is something else entirely. Fitting all the pieces into place and getting all the relevant, variously located actors to move at the same time is invariably a painstaking and frustrating task, as anyone involved in combatting counterfeit drugs can tell you.

The problem of fake pharmaceuticals is growing all the time. According to recent research by the European Union Intellectual Property Office, they cost the EU €10.2 billion a year, money that manufacturers and distributors might otherwise have spent supporting an estimated 37,700 jobs. According to the World Health Organization, a third of counterfeit drugs in the world contain no active ingredient, while 20% contain the wrong one, or the incorrect amount, leading to a million or so unnecessary deaths a year. Too many pharmacies see suspiciously alluring offers from wholesalers and fail – knowingly, or otherwise – to raise the red flag.

It is widely accepted that serialisation – the act of putting a unique ID code on every package of pharmaceuticals – should be a key component of anticounterfeiting efforts, but there are so many complex dimensions to consider and such an array of priorities to juggle that efforts to get a comprehensive system in place have moved slowly. Pharmaceutical companies in the US had to be partially compliant with Food and Drug Administration (FDA) serialisation regulations by 1 January 2015, with the phase-II deadline falling in November this year.

In the EU, the Falsified Medicines Directive kicks in at the start of 2017, after which all pharmaceuticals packages will contain a unique identifier, and there will be tougher rules on inspections and record-keeping. The law will affect all research-based manufacturers, generics producers, packagers, wholesalers and distributor: pretty much anyone looking to supply the EU with prescription drugs (and some of the over-the-counter variety).

Outside these two regions, however, a patchwork exists of different approaches to serialisation. Many governments have launched their own policy initiatives, some more detailed and substantial than others. Argentina, Turkey, Brazil, South Korea and India (for exports only) require reporting to a central system, while Serbia, Greece and Italy, among others, have some basic record-keeping regulations in place. A lack of global standardisation means that there are still far too many points of weakness in the supply chain, which criminals are more than happy to exploit.

Then there is the technological dimension. Serialisation consists of multiple automated processes and data exchanges taking in devices such as cameras, printers, and the computers and tablets used by site managers, logistics overseers, quality control staff and regulators.

 There is no common standard for information exchange, just a ragtag of bespoke systems designed by a variety of different technology providers.

Harmonised, standardised and safe

This is where Open Serialization Communication Standard (OPEN-SCS) group is looking to make an impact. A working group consisting of representatives of the pharmaceuticals and technology industries such as Pfizer, SAP, Advanco and TraceLink, OPEN-SCS aims to create a “usable standard for life sciences companies implementing serialidation technologies for tracking pharmaceuticals through national and international supply chains”. The group has met twice, the last time in Germany in September, with its next meeting set for the first quarter of 2017.

We hope that the current work being completed by OPEN-SCS members will gain traction across different markets, and that there will be a common desire to all players to unite, so that we can have common standards to evolve towards serialisation in a cost-effective and streamlined way.

“There are many differences between countries, but manufacturers typically operate on a global level,” explains Marcel de Grutter, the group’s executive director and project manager in Abbott Pharmaceuticals’ serialisation and regulatory affairs division. “This creates quite a complex situation whereby manufacturers have to set up different manufacturing lines to comply with different country requirements.

“Also, different data have to be exchanged between many systems and stakeholders, including third-party manufacturers, control systems, logistics service providers and governmental systems. A standardised approach would bring various benefits for the industry.”

OPEN-SCS is an offshoot of the non-profit OPC Foundation, which has developed communications standards for many different automated industrial processes over the years. The idea of its creation came from pharmaceuticals inspection technology providers Optel Vision and Systech, which wanted to create an open communication standard, independent of proprietary architectures and data exchange protocols, but under the auspices of a neutral industry-wide organisation that was not driven directly by companies with unavoidable conflicts of interest.

OPEN-SCS has identified several goals it would like to achieve. These are the creation of a set of standards for serialisation compliance to be overseen by a global governing body; the provision of funding to hire serialisation experts to support this body; solutions to address the high cost of the manufacturing set-up due to a lack of global standards; stronger security during the manufacturing and distribution process; privacy parameters and encryption requirements for the import and export of products; more efficient exchange of information between systems; and the alignment of vendors and systems to a common set of standards and regulations.

These goals will initially be targeted at the weakest part of the supply chain, the gap between the manufacturing or packaging site and the pharma company that contracted it (Levels 3 and 4). At the moment, serialisation data is shared between the two links in a variety of ways, with different tech providers offering up an array of systems solutions. A standardised approach would make it easier for different suppliers to work together, and allow the easy integration of contract manufacturers into the supply chain.

“It would also save time and money in terms of having standardised norms that don’t require many customised steps in the manufacturing process, a faster implementation, a facilitated process for the validation of compliance of the overall documentation, as well as long-term sustainability,” says de Grutter: “Traceability through serialisation involves many elements and stakeholders. As awareness is rising, stakeholders now better understand the advantages it can present, and are now including this as part of their planning and business processes and systems in manufacturing and supply chain.”

Sprawling, bumpy network

As is the case with any new system, there are question marks about the potential costs associated with the transformation, particularly on the part of companies that have invested in bespoke systems. According to Pharmabiz.com, as of October, around half of Indian pharmaceuticals companies were at risk of losing their US business having failed to comply with FDA regulations. This suggests how hard it will be to bring emerging-market players, in particular, into OPEN-SCS’s standardised system.

De Grutter acknowledges that the associated up-front costs have discouraged companies from emerging markets. Though the proof will be in the pudding, he believes that whatever OPEN-SCS comes up with will be cost-effective and scalable, representing lower costs and risks to all, at least over the longer term. Many companies have been slow to update their serialisation systems because of uncertainty about the kind of coding technology they should employ, whether thermal ink jet, thermal transfer overprint or something else. The creation of clear standards should hopefully spur these companies into action.

“OPEN-SCS is targeting players from different markets and industry sizes – from small companies to global ones, and in both emerging markets and developed markets,” de Grutter says. “This is important as we strive to have a common standard, accepted globally, by all stakeholders including governmental authorities.

Traceability through serialisation involves many elements and stakeholders. As awareness is rising, stakeholders now better understand the advantages it can present, and are now including this as part of their planning and business processes and systems in manufacturing and supply chain.

“We hope that the current work being completed by OPEN-SCS members will gain traction across different markets, and that there will be a common desire to all players to unite, so that we can have common standards to evolve towards serialisation in a cost-effective and streamlined way.”

Looking ahead, as well as continuing to flesh out the outlined goals, OPEN-SCS will aim to recruit more members, giving it a broader range of insights into what the new system should offer and giving it the money to pursue multiple goals in parallel.

Adriano Fusco, the group’s marketing director, acknowledged in an interview with Packaging Digest that exposing OPEN-SCS to small and mid-sized pharma companies, with less experience of serialisation, is a priority.

As internet and computer access becomes more widespread, the counterfeit pharmaceuticals business is sure to grow with it. The web has given criminals anonymous access to countless distribution channels, and enabled them to disappear into the ether as quickly as they arrived. Serialisation could prove the most effective deterrent, with unique coding making it much easier to identify illicit products and harder to pretend that you didn’t know an item was fake.

It will only maximise its potential if all interested parties can easily exchange information, the noble cause to which OPEN-SCS is dedicated. The fact that technology companies are on board, even though they potentially have the most to lose through the arrival of standardisation, bodes well for the success of the project. 



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