Since 2007, when Turkey mandated drug pack identification and aggregation and France required the use of a data matrix code to identify all drug packs dispensed in pharmacies, regulations have been appearing throughout the world to battle against counterfeit drugs. These regulations have paved the way forward for major changes in the pharmaceutical industry that will gradually lead to a fully fraud- and counterfeit-proof global supply chain.
Drug pack serialisation, as defined today by the EU Falsified Medicine Directive, is the tree hiding the forest for several reasons: many countries are undergoing a comparable approach, aggregation is very likely to follow immediately afterwards and a number of applications will derive from mass serialisation in the future.
The first step to implementing serialisation is the in-line printing of the relevant code and information on each unit pack. The Turkish and French pharma plants’ early requirements revealed the risks and difficulties linked to in-line printing of a 2D code and it took three years to deal with them.
The major challenge was to obtain a high level of reliability at line level to:
- Ensure that packs are correctly printed so as to be read with no errors down the line and the supply chain, and
- Avoid a decrease in packaging line output.
The printing process, using either Thermal Ink Jet technology (TIJ) or laser marking devices, has reached a high level of reliability today, as have the cameras checking the printed code and data. The difficulty wasn’t only how to print and check the codes but also how to maintain timely performance while changing the format on the packaging line. Unfortunately, due to the multiplication of product presentations and markets, batch partitioning is a growing trend in the pharma industry, resulting in more format changes, especially for contract manufacturing organisations (CMOs).
In light of these difficulties, vendors have developed a new type of machine that is dedicated to marking 2D code and variable data – Mark&Verify Modules. M&V Modules integrate a marking device, a camera and an eject station. They aim to secure the printing process while facilitating the role of line operators when proceeding to a format changeover. Moreover, these modules are brought into the packaging line once they have been factory acceptance tested, hence reducing the risk of production downtime when implementing serialisation.
The serialisation process starts at the pharma production stage by generating, marking, capturing and consolidating data in a secure way
In addition to product identification, industrial anticounterfeit strategies also rely on tamper evident (TE) labels for product integrity. Some M&V Modules therefore integrate TE labelling machines. An appropriate M&V Module is the first step to implementating a successful serialisation project.
The second step to implementing mass serialisation involves data exchange. Currently, in France, traceability is carried out at batch level. The data matrix code, including the product code (GTIN), batch number and expiry date, is read with barcode readers in the pharmacy. In the future, the unit pack, identified with a unique serial number, will supply a method to prevent counterfeiting and reimbursement fraud by making verification possible at the point of dispense. However, the serialisation process starts at the pharma production stage by generating, marking, capturing and consolidating data in a secure way.
This step involves considerably more stakeholders within the pharma company than the first step (marking and verifying a 2D code and character strings). This stage mainly involves packaging personnel who implement packaging line modifications and item artwork modifications.
There are two approaches to implementing serialisation at a pharma plant level:
1. A bottom-up approach driven by packaging machine stakeholders
2. A top-down approach driven by Information Technology stakeholders
Until now, the first approach has been the most common because it is a straightforward solution that most Mark&Verify Modules vendors provide. It relies on a local database at line level, with each packaging line having its own database and making the data available for the level above, which has then to be defined. On the one hand, taking this approach is interesting because the user requirement specification (URS) is simple to prepare, the validation work is done quite easily and the initial installation is fast. On the other hand, when interfacing such solutions with existing Enterprise Resource Planning (ERP) systems, additional software adaption work is required, thus leading to customised solutions with major disadvantages, among which are software upgrades, qualification purposes, production stoppage and data storage.
Software upgrades are fastidious because each line has to be upgraded individually and it is necessary to stop production in the process. After that, each line has to be re-qualified individually before production can recommence. Serialised batch data is stored locally and is therefore at risk. Moreover, with the amount of data growing over time, storage capacity will sooner or later become saturated at line level.
Top-down approach
The second approach relies on a top-down analysis of corporate IT requirements, taking into consideration the features of in-line marking devices and cameras. Naturally, this requires corporate input and therefore all serialisation projects should start with the establishment of an executive serialisation team. Although the URS is more complex and time consuming to establish, with more time and capital investment required for the first pilot line, the total delivered value (or total value of ownership) using this top-down approach is far superior.
The serialisation process starts at the pharma production stage by generating, marking, capturing and consolidating data in a secure way
The reason for this is that only a few suppliers, such as the French company Adents, which chose this approach, have developed a dedicated serialisation platform under the form of standard software, which can be set up to suit any in-line marking device and camera in the market.
The benefits of such a software platform are huge. First, one version of the software runs on all packaging lines worldwide, independent from the customer, from the type of in-line marking and camera devices and from the existing ERP system. Second, the platform runs in parallel with the existing ERP and Manufacturing Execution System (MES) and interfaces with them only to exchange data relevant to the serialisation process.
Third, the platform is structured in such a way that no batch data is ever stored in a local line level database. Critical data is consolidated and saved on a plant level server that supervises the serialisation process. Finally, upgrading the platform is a standard process, which is carried out without having to stop the production line and without having to re-qualify each line individually. It goes without saying that the upgrade process should be considered seriously given that regulations will multiply and evolve in the future.
Software companies choose the top-down approach while packaging machinery manufacturers prefer the bottom-up approach. Both are complementary and have led suppliers to offer solutions that partially overlap. Currently, no supplier offers a solution that covers the full scope of a serialisation application. However, were a supplier to collaborate with a relevant partner they would offer more than required.
It is as difficult for a software company to become a packaging machinery manufacturer as it is for a machinery supplier to become a software company
It is as difficult for a software company to become a packaging machinery manufacturer as it is for a machinery supplier to become a software company. Therefore, the only way for a supplier to implement a serialisation project successfully is to collaborate with its counterpart. Since the IT driven top-down approach is becoming more frequent among pharma companies, it will probably require most machinery suppliers to step away from the data exchange part of the project.
For several reasons, implementing a serialisation project is even more difficult for CMOs than for Big Pharma labs. CMOs have to deal with an ever-increasing number of different sized batches and, fortunately for them, an increasing number of customers. Format changeovers are becoming more frequent on their packaging lines, affecting productivity and costs, while the number of batches to serialise and the number of customers is making data exchange with event repositories more complex.
Even though regulations are converging worldwide towards mass serialisation, data exchange is likely to increase not only in volume but also in complexity as pharma companies shift from an integrated model to one increasingly relying on CMOs. The performance of the serialisation process is key to a CMO’s success in the future.
Anticounterfeiting regulations are driving major changes within the industry and the drug supply chain. The huge number of production plants and packaging lines to be equipped with serialisation solutions requires the pharma industry to invest billions of euros over the coming years.
Unsurprisingly, solution providers lack resources to address this huge market demand and are therefore recruiting massively in the fields of software engineering, project management and sales. Moreover, serialisation is leading the way to future applications and smart-apps, in some cases further involving healthcare systems, patients, medical doctors and pharma companies. In this sense, serialisation is the tree hiding the forest.
