For all pharma brands the need to comply with serialisation legislation has in some cases meant major changes to their businesses. The challenge facing the industry is to transforms their processes and supply chain. As Dave Howell discovers, pharma packaging design and manufacture is changing how pharma brands are approaching serialisation
With two years to go until the Falsified Medicines Directive (FMD) comes into force in the UK and with the Drug Supply Chain Security Act (DSCSA) in the USA due at the end of 2017, developing and implementing a strategy to comply with these directives is vital.
Large pharma brands are largely on track to meet the serialisation deadlines that have been set. Mid-tier and smaller pharma brands are however, struggling to a degree with the organisational and structural changes that are needed to create and then track individual drug packs.
“Pharmaceutical brands that are using multiple outsource partners will need to assess their outsource partner network with a view to decoupling their CMO and CPO functions,” Jonathan Laverick, commercial director, Sharp Europe told Packaging Today. “Given the complexity of any serialization implementation, there is a distinct benefit to consolidating your CMO/CPO network into fewer packaging and serialization hubs.
Laverick continued: “Consolidating into fewer packaging sites will offer considerable savings – both financial and resources – when starting-up serialization projects. The financial burden associated with introducing line and site level serialization systems and serialized data transfer systems is considerably lessened when using fewer packaging sites. Consolidation means that both logistical and financial demands are streamlined. Benefits of scale can also be realized with greater volume being packaged by fewer sites.”
The level of integration that is needed to meet the stringent tests the new legislation lays down, means levels of supply chain and partner integration are needed that have been unprecedented in the industry.
Value and process
How pharma brands approach their compliance with the serialisation legislation are manifold. As Rupert Taylor, global category manager, Healthcare and Personal Care, Essentra points out, for most companies the impact will be profound: “Though serialisation is ultimately an ‘upgrade project’, it is much more complicated than that. The process will mean that every point within the manufacturing chain will have to carry out a stop-check, resulting in the collection of a large amount of data. Therefore, IT infrastructure must be redesigned to enable them to store the volume of data necessary and companies need to ensure that all systems within the supply chain are aligned.”
In addition, Marco Baietti, commercial director, SEA Vision said: “Some serialization solutions allow a very strong integration of packaging lines with automated processes governed by enterprise resource planning (ERP) and manufacturing execution systems (MES). With a marginal fee over standard serialization solutions, it is possible to connect all packaging lines to the same platform, giving enormous advantages in terms of reducing manual operations and consequently risk of errors and time savings. Today, it is possible to start a batch on a complete production line from a single point and collect all production data, resulting in a unique report of all packaging line events, all without the need for a costly SCADA system.”
Clearly the cost of implementing serialisation across a pharma’s businesses can be vast, with system integration a key component, as Jean-Marie Aulnette, VP, Europe, Middle East and Africa (EMEA), TraceLink explained: “The average cost of implementing a solution across each production line is $250,000. Consider that some large manufacturers may have up to 100 lines to upgrade and equip, and the financial burden is clear to see.
“Communication with partners is also potential hurdle,” Aulnette continued: “In many cases, marketing authorisation holders (MAHs) will need to exchange data with external partners such as contract manufacturers and 3PLs (third-party logistics companies), who may or may not be ready for serialization. Pharmaceutical companies must assess their eco-system of partners working for and with them to ensure preparations are well underway. Generally, big pharma companies have a more complete picture of what they must do to comply with changing market regulations, while small and medium-sized players may be falling behind. It’s important to communicate with all partners and ensure they are integrated into your supply chain.”
Time is of the essence to meet the current timeline for serialisation. Pharma brands also need to think about the future. The capacities they have today may be outstripped in a short time making building into their processes scalability a critical component.
TraceLink for instance have their Life Sciences Cloud, the largest globally networked track and trace pharmaceutical ecosystem for the storing and transferring of serialization data. The cloud-based model, hosted by Amazon Web Services, means the system can be adapted to volumes now and in the future, with the ability to handle massive sets of data in ways that traditional, on-premise systems cannot.
Advances in communications technology could also deliver the ultimate goal of serialisation across pharma. Intelligent packaging that doesn’t use printed identification, but technology such as NFC could herald a new age of drug tracking and traceability.
Essentra’s Rupert Taylor also pointed out: “Essentra believes that multiple layers of solutions must be used in order to ensure that drugs are thoroughly protected – including serialisation, tamper verification and more intelligent packaging tools such as conductive inks or RFID. To reassure the whole supply chain of a drug’s security, different practices must be used. The key to delivering a successful pharma security system is to use both overt and covert technologies, supporting all parties within the supply chain, from retailers to patients.”
Specialist labels have been used for several years as unique identifiers. The serialisation legislation will see these traditional marking processes joined by more sophisticated systems that use the capabilities of the ubiquitous smartphone coupled with secure cloud-based services to deliver a safe drug supply chain.