Traditionally, contract manufacturing organisations (CMOs) have assumed responsibility for both drug manufacturing and packaging of products. However, in recent years contract packaging organisations (CPOs) have taken a more prominent role in the pharmaceutical supply chain in response to growing demand for more efficient, and often intelligent, packaging processes.
Packaging requirements are growing increasingly complexas more innovative products are brought to market and regulations are introduced, evolved and sometimes removed across global markets. The Drug Supply Chain Safety Act (DSCSA) in the US and the EU’s Falsified Medicines Directive (FMD) have both created increased demand for pack re-designs and an overhaul of entire packing processes. Specialist packaging companies, with in-depth knowledge of market requirements and the flexibility to tailor solutions, have become a vital part of the supply chain. Driving this growth are three trends which are causing fundamental changes across the pharmaceutical industry: postponement, serialisation and digitisation.
Traditionally, CPOs provided a bulk packaging service where large volumes of pharmaceutical products were packed, then shipped before being stored in a warehouse until the product was required. Due to volatile market demand, this approach quite often produces a lot of waste product and can also incur high inventory costs in multiple locations.
In recent years, companies have started to explore late-stage customisation or postponement packaging, whereby blank market-agnostic product components are stored in a central warehouse and only customised for a specific market when there is demand. The product can then be shipped within hours of receiving the order.
While there are some specialised CPOs that are already equipped to package products in this way, adoption of postponement packaging has been sporadic, with some companies reluctant to tackle its complexity or invest in new processes and infrastructure, which, for medicines, can be a substantial undertaking.
Nonetheless, as nuanced interpretations of the FMD, as well as domestic regulations and the need to cater to different languages create a need for more flexible packaging processes, postponement is becoming more attractive to companies supplying to multiple markets. In this kind of environment, postponement offers huge opportunities to improve efficiencies, reduce costs and waste, and lower the likelihood of reworks being required.
In the longer-term, postponement could overhaul the way that healthcare is delivered to patients, leading to patient specific packaging, ultimately increasing patient safety and adherence.
Serialisation has been widely discussed across the industry since the FMD and DSCSA regulations were first announced and the implementation of new systems to meet legislation will have a lasting effect on the industry.
The introduction of mandatory barcodes and the management and transfer of the huge amounts of data generated by serialisation has increased the complexity of pharmaceutical packaging and created significant cost-barriers. Consequently, many drug manufacturers and CMOs have been slow to adopt serialisation. However, it’s vital that companies look beyond these challenges and see the scope of serialisation systems, which will not only lead the industry towards a safer and more secure supply chain, but ultimately help to connect the whole industry, from manufacturer to patient.
Streamlining the exchange, interpretation and processing of data across enterprise systems and through entire supply chains has huge potential. Companies will be able to look at legacy data and optimise their logistics operations through real-time monitoring, resulting in accurate demand planning as opposed to assumption-based forecasting, as well as improved warehouse management, shipment visibility and more efficient distribution.
Ultimately this could mean a safer, more integrated and faster approach to bringing new drugs to market, to the benefit of patients and primary healthcare providers.
Digitization of the supply chain
Serialization is forcing businesses to move towards a more digital approach to data management and exchange, but it is not the only catalyst for change. To take full advantage of digital supply chain processes, companies first need to address their internal operations and capture data in a way that is readable, and usable, by computerised systems and analytics tools.
Better visibility of a business’ value stream could not only give organisations the ability to make better informed decisions but will also pave the way for the implementation of automated processes and well-targeted and measurable process improvement projects.
Companies who take a proactive approach to developing their packaging solutions and incorporating full track and trace and postponement into their operations will inevitably find themselves in a better position when these new digital processes become more widely adopted. It is important that the industry continues to drive these developments forward to fully realise the broader impact on supply chain management.