On the home stretch to the serialisation deadline

With serialisation legislation looming, Manufacturing Chemist spoke to David Carpentier, founder and CTO at Adents, to discuss what pharma manufacturers should be considering as the countdown to the EU Falsified Medical Directive enters the home stretch

MC: How can companies ensure compliance?

DC: To ensure compliance, pharmaceutical companies need to master scalable data management capabilities at the enterprise level. Only clean serialisation and product master data can be reported to authorities. The same goes for manufacturers, who will need to report commissioned serial numbers correctly back to multiple MAHs. Lasting compliance in terms of changing legislations, new regulations or future markets, with as little impact on productivity as possible, can only be achieved through central configuration with site-level solutions.

MC: Is compliance just a cost issue and what else should companies keep in mind?

DC: It is very important, apart from best-in-class equipment, to choose the right software to avoid hidden costs in the long run. Obviously, price will always be a consideration, but companies must understand that serialisation is a long-term, rather than a short-term, solution. So, the most important factor in choosing a serialisation solution is whether it is best adapted to your overall needs. Failure to do so can be very costly in the future; for example, if the solution isn’t hardware-agnostic, a manufacturer may find itself tied in with a certain machine and device provider, which can make overhauling or upgrading a machine line-up with the most suitable equipment difficult. Typically, implementing a new regulatory requirement involves multiple configuration steps — which are then exponentially expanded by the number of lines used for the market, and then multiplied again by the number of aggregation levels, if applicable. If regulatory information is configured centrally at site level, however, information can be simply transferred to individual lines rather than hardcoding at each and every line (for which you will probably have to pay your solution provider).

Hardcoding at each line — plus validation, documentation and qualification efforts for each and every change made — takes a lot longer than merely validating and documenting the centrally made configuration, and also comes with the added risk of human error. Finally, all monetary costs aside, manufacturers must secure internal resources to carry your serialisation project forward and ensure that everyone gets the right training to ensure the correct use of your solution.

MC: What technologies/software are available to expedite the process?

DC: Adents Prodigi entered the market as the only cloud-based traceability solution that can centrally manage regulatory requirements mandated in the pharmaceutical industry, connect multiple trading partners and allow pharmaceutical companies and CMOs to benefit from the massive amounts of data generated during the serialisation and track & trace process. Centralising all serialisation information at enterprise level helps companies to keep control of their serialisation data — it avoids duplicate serial numbers across multiple sites and manufacturing organisations and thus ensures clean data sets.

Via Adents Prodigi, Adents became the first European provider to offer a certified “Gateway” to the European Medicines Verification System (EMVS). Furthermore, Adents Prodigi opens up new horizons beyond regulatory compliance in terms of data analysis (including Microsoft Power BI), machine learning tools or additional capabilities through existing in-house or third-party solutions.

Meanwhile, Adents Seriza incorporates various subsets of the company’s groundbreaking track & trace platform, comprising a fully configurable, standardised solution for unprecedented levels of flexibility and scalability for pharmaceutical manufacturers and packagers. Given the looming serialisation regulatory deadlines in both the EU and USA, however, perhaps Seriza’s most important benefits are its speed to deployment and ease of integration.

Adents Seriza comprises two primary tools. At the site level, Adents Supervisor manages and distributes serialised codes. Deployed on a central server at each production site, the module is the key central component of Adents’ serialisation and aggregation suite. All line configurations are handled at the site level, leading to quicker implementation and scalability while greatly reducing the effort to revalidate lines when changes are made. At the line level, Adents Pilot drives the printing of unit codes and controls their conformity. The solution directs printing and vision systems, and manages communication with line equipment to deliver a customer’s choice of item-level serialisation, item-to-bundle aggregation, bundle-to-case aggregation or case-to-pallet aggregation.

MC: Will we make it? Is it too late?

DC: Although implementing Level 4–5 solutions should be relatively straightforward for a capable provider, the level of serialisation readiness at site-level is still concerning, as implementation at line/site level can take several months, depending on the scale of the project. Add to that the need for the potential onboarding of stakeholders, supply chain partners or connections with authorities, and it’s easy to see why time is of the essence.

This is reflected by a recent statement from the European Medicines Verification Organisation (EMVO), warning that June 2018 is the very latest that manufacturers should commence the EMVS connection process or risk being non-compliant in February 2019. This means that, by June, companies will need to have chosen their serialisation solutions, and implementations must have advanced far enough that you are able to test these systems’ connection with the European Hub. If you want to kill two birds with one stone, you should opt for a solution provider that is a certified EMVS Gateway Provider, such as Adents. This ensures your solution will be hooked up with the EU Hub as quickly as possible. Clearly, if MAHs and CMOs have not chosen their solution/solution provider yet, or need to change their solution, they need to act ASAP, especially considering the likely bottleneck situations arising from the inevitable serialisation scramble. With an adaptable, centrally configurable, prequalified solution, and with the help of a reliable system integrator, it is certainly possible to reach compliance by February 2019 for manufacturers who commence the process post-haste.

MC: Beyond simply being compliant what are the long-term benefits?

DC: An enterprise-level serialisation solution centralises information coming from formerly disconnected universes, incorporating tracing capabilities all the way to the point of consumer dispensation. Thus, it provides unmatched visibility at all levels. If, like Adents Prodigi, your solution comes with built-in access to powerful business intelligence tools, it can cross-reference and analyse information from these formerly disconnected environments.

Connected with other tools such as MES, ERP or CRM, it can even uncover causal relationships between previously unconnected information and seemingly unrelated incidents. To cite some practical examples of problem solving and optimising to drive down costs:

  • by connecting production information at all levels and across sites and manufacturing organisations, enterprise-level serialisation solutions can offer detailed insights into global production, thus comparing and optimising OEE globally and locally
  • global visibility and time-stamped incident reporting are helpful for comparative trend analyses
  • previously unconnected information and seemingly unrelated incidents might bring to light causal relationships that can then be resolved
  • real-time visibility at all levels offers actionable insights to optimise production and packaging processes; that is, by reallocating certain products to more suitable production lines
  • if a pharma company utilises the full potential of its Level 4 track & trace solution, it could, for example, cross-reference supply chain information with data coming from cold-chain monitoring systems or supplier information for a more comprehensive picture of what happens to products before and after packaging.

MC: Will we ever see a global standard?

DC: Whether it’s standard data exchange protocols, file formats or data carriers to facilitate communication between different serialisation systems, or standardised implementation to facilitate validation, qualification and replication across multiple lines or even sites, universal standards can make life easier for everyone.

Industry leaders, business associations and organisations such as the GS1 Working Group are also working towards harmonisation and standardisation. Many of those standards are already widely used if you think of Global Trade Item Numbers, GS1 2D barcodes, etc. More and more countries realise the advantages of standards as well, and are incorporating (or at least recommending), for example, GS1 standards in their legal framework pertaining to serialisation and track & trace.

But, as desirable as standards are, they will be very difficult to implement expeditiously at a global level, as different types of information historically come in different file formats (for example, consider product master data, batch reports, logistical data or government reporting). Therefore, Adents has developed its enterprise level serialisation solution, Adents Prodigi, in a manner that ensures it can handle all broadly used formats as well as adapt to proprietary ones.

MC: Can pharma actually handle the volume of data involved?

DC: Only the scalability afforded by the cloud can handle the vast amount of data generated through track & trace processes. When it comes to the exponentially increasing amounts of data generated through track & trace processes (serial numbers, master data, aggregation information, event reporting, etc.), most in-house systems quickly reach the limits of their capacities. Cloud solutions offer powerful platforms for unlimited data storage, accessible anytime and anywhere. Your solution should also be able to export clean data in multiple formats to ensure correct data exchange with all parties concerned. In addition, the adaptability of the cloud helps to keep the cost of managing data down as you only pay for the resources you actually need while being able to upgrade quickly.

If you opt for an open architecture capable of adding, in addition to data storage and management capabilities, analytics applications such as Microsoft Power BI, you will be able to parlay your compliance costs into business investment, as you can make actionable use of serialisation data. Cloud solutions such as Microsoft Azure, on which Adents Prodigi is natively built, also ensure data compliance in all countries in which a pharma company operates through local data centres; this means that companies always know exactly where their data is stored, and provides enhanced security features such as strict access control and strong encryption algorithms.

MC: Moving forward, what are the benefits of aggregation?

DC: One of the benefits of aggregation is compliance, as aggregation is (or will be) required in countries such as the USA and Brazil. Aggregation also has its advantages when it comes to certain logistical processes, such as product recalls or market withdrawals, tracking and tracing, and more. Scanning a case or pallet to know what’s inside takes a lot less time than unpacking and scanning each individual item. Opened pallets are also easier to tamper with (such as by introducing counterfeit products that might only be discovered upon verification before dispensation). Aggregation also makes localising units (if a batch needs to be recalled, for example) a lot easier: if you know which pallet a certain serial number is supposed to be on, all you have to do is look for the pallet in question. Therefore, many distributors may actually ask for aggregation rather than just serialisation, even if not legally required.

In particular, CMOs that can offer aggregation as an added service may reap a huge competitive advantage, allowing pharma companies to take their supply chain partners’ requests into account when meting out manufacturing contracts.

Training is another consideration here. Training line operators one time on a new SOP and new documentation can be more efficient than implementing a non-aggregation solution now … and then having to redo all the SOPs, operator training and additional qualification at a later stage. This also avoids potentially realising that the chosen serialisation solution cannot handle aggregation or doesn’t have the flexibility to easily integrate aggregation equipment.