Worldwide, the regulations governing the serialisation of medicines are becoming more complex and extensive
Pharmaceutical companies and packaging service providers are obliged to give consideration to this landscape when selecting an appropriate software and database solution for serialisation and track and trace applications. They must seek to identify a solution that not only complies with all the current international requirements, but also with future needs.
When selecting suitable serialisation software, it is crucial for pharmaceutical companies and packaging service providers to ensure that it not only satisfies the existing serialisation regulations, but is also capable of accommodating changing requirements. This applies in particular to the increasing complexity and scope of serialisation projects and specifications that are currently being initiated and implemented in many nations across the globe.
It is essential to understand that a supposedly quick and easy solution can have a detrimental impact on productivity, efficiency and security in the packaging and labelling process. Given the constant consolidation of requirements and processes, it can prove to be impossible to make changes quickly, and additional costs can be incurred. Preference is to be given to software with a system architecture that can expand to accommodate growing requirements and future needs (both regulation and workflows).
As a general rule, the software is the most crucial component of a serialisation project and is therefore not to be regarded as merely an adjunct to hardware components or an update for existing programs. But what criteria should a user apply when searching for an appropriate serialisation software solution? What are the most important factors? The discourse that follows provides some answers and serves as an aid to decision making.
The serialisation of drug packaging, which will become mandatory in the USA from November 2018 and in the EU from February 2019, and is already prescribed in China and Turkey, presents a major challenge to pharmaceutical manufacturers and packaging service providers regarding suitable databases and software solutions.
In the past, companies implementing a serialisation project for the first time often focused on the hardware required within a packaging line to apply, inspect and, if applicable, save locally the relevant codes with serial numbers on secondary packaging according to ISA-95 Levels 1 and 2 (machines and single packaging lines). It is now considered better practice to give closer consideration at the outset to the appropriate configuration of a database solution that is also capable of reliably controlling and managing the necessary processes across multiple lines (Level 3), sites or the whole company (Level 4); see Figure 1.
The list of requirements is long. It ranges from the secure generation, management and storage of serialisation and aggregation data, as well as their transfer to national authorities, wholesalers or logistics partners, to the integration of existing or new hardware components and simultaneous production management for multiple lines. At the same time, data security must be ensured and productivity maintained. Against this background, many pharmaceutical companies and packaging service providers have serious concerns relating to reliable implementation. In most cases, it quickly becomes evident that an “off the peg” software solution is unable to offer compliance with the complex and diverse requirements of serialisation and track and trace applications.
The problem is well illustrated by way of an example. Pharmaceutical company A produces an expensive cancer drug in relatively small quantities on a single packaging line, but distributes it worldwide and has to comply with numerous country specific regulations. Contract packer B, by contrast, packages medicines for a variety of customers in large quantities, but the products are destined exclusively for local distribution.
Both companies must address the issue of serialisation — but their requirements concerning processes, workflow and data transfer could hardly be more different. At the same time, neither company A nor company B is usually able to rule out having to offer a completely different range of services, even at very short notice, as circumstances change.
It therefore follows that the software architecture of serialisation and track and trace solutions should be sufficiently modular to allow flexible configuration according to the individual user’s processes and requirements. In the absence of modular architecture, the software has to undergo costly revision, which ultimately adds to the user’s costs.
Given the certainty of future changes to processes and regulations, the ability to expand functionality and increase the scale of processes (such as the number of lines or aggregation levels) are also highly important factors — as illustrated by the most recent developments in China and Brazil. If the software is unable to accommodate such changes, significant additional costs can arise each time the serialisation or packaging process is modified. Furthermore, the software has to be completely revalidated, which, in many cases, represents the bigger cost factor regarding the need of time.
To identify an appropriate software and database solution, the first step should be to conduct an internal examination and analysis of the existing packaging process. Key questions in this context concern where customer and production orders are initiated, and how the serialisation data are reported back to authorities. If this is to be done through an existing enterprise resource planning (ERP) system, the serialisation software must have appropriate interfaces, and a suitable process has to be defined. If an interface to an ERP system is not required, the software should be able to generate the orders and manage them efficiently, even in complex cases.
Another important criterion for the software solution can be the visualisation of warehousing or logistics processes, as required when repackaging and making up consignments for wholesalers — especially when aggregation is required.
No matter whether one or several medicines are being produced and packaged at the site, the complexity of the operation increases as soon as the product has to be exported to several countries where different regulations apply. In China, the serial numbers are provided by the authorities; in the EU or US, they have to be generated by the serialisation software. In addition, some regions prescribe consecutive serial numbers, whereas others apply the random principle (Figure 2). The general rule applies that serial numbers belonging to a defined range cannot be issued more than once. The numbers can be based on a Global Trade Item Number (GTIN), an identifier for trade items developed by the not-for-profit organisation GS1.
As a consequence, the serial numbers contained in the codes must be held on file for a predetermined period. It may also be necessary to run comparisons to recognise duplication if the numbers are allocated by an external source, as was the case in China and is envisaged for the future by Russia. Depending on the region, the serialisation data may have to be stored for at least 6 months beyond the medicine’s expiry date — or even for several years beyond the production date. This aspect is not to be underestimated, including when storage capacity is being specified for the necessary servers and other hardware.
It is to be assumed that the currently valid or imminent coding principles in individual countries and regions will be revised sooner or later, and that additional countries and new regulations — Russia is on the horizon — will need to be accommodated. If it is to be future-proof, the software solution must therefore be designed so that it can be adapted to suit changing circumstances. The greater the extent to which the serialisation and track and trace processes can be configured in-house without any programming, the faster the response and the lower the costs will be when changes need to be made.