The previous post ‘Five key considerations for successful serialisation implementation‘ highlighted the importance of a cross departmental holistic approach to the successful implementation of a serialisation project. This final post in the pharma series explores how serialization can create new paradigms of doing business, while becoming a transformation agent for how enterprises operate within the supply chain.
At a time of upheaval and uncertainty, it pays to reframe perspectives on serialisation from “yet another compliance burden” to an opportunity to optimise and innovate within the pharmaceutical industry, given the significant potential business benefits.
Patient safety and brand protection – patient safety is the very foundation of the legislative/regulatory process and needs little explanation. Serialisation is perhaps the most effective weapon available to fight counterfeiting, safeguard consumer trust and protect revenues. To that end, serialisation can play a key role in a robust brand protection strategy by detecting and combating counterfeit products sooner. It should also translate into a reduction in product diversion incidents (whereby genuine product is fraudulently diverted into unintended markets).
Innovation is driven by insight, so life sciences companies should jump at the chance to support advanced analytics initiatives to put Big Data into meaningful context. This might include the ability to track regimen compliance, sending refill reminders based on analyses of prescription and authentication data, or informing the development of precision medicine.
Returns processing and financial controls – serialisation can help to ensure refunds are only paid once for the specific drugs that are returned. Recalls will also become more laser-guided, targeting individual pharmacies or regions rather than widespread national recalls, leaving greater quantities of viable product available to the patients that depend on them. If faced with a product recall, organisations will be able to respond much faster and limit the risk of reputational damage.
Business and supply chain optimisation – serialisation presents a transformational opportunity to review and, if necessary, renew business processes, data flows and applications from production through the supply chain, promoting interoperability in the process. Companies should seize the chance to streamline underlying processes and deliver a single version of the truth, which will improve visibility into inventory at all nodes of the supply chain and help increase the accuracy of sales forecasts. Serialisation calls for tighter in-process controls, documented risk mitigation strategies, enhanced technology and stiffer validation controls, all of which can help to avoid recalls in the first place by revealing labelling errors or defects while the product is still under the manufacturer’s control. With better visibility of product moving through the supply chain, shrinkage or losses can be reduced. When data can be reviewed with greater ease and frequency, expiry dates can be managed more efficiently through regular stock controls, minimising the need for costly write-offs.
Above all, this industry-wide initiative invites businesses to foster greater engagement and collaboration among internal teams that can lead to lasting cultural and behavioural change, and drive real innovation as well as continuous improvement.
Mass serialisation within the process manufacturing industry is not new, for example food and beverages, where counterfeiting has long been rife and highly lucrative. Serialisation is already empowering these firms to tackle a series of food safety and consumer protection challenges to support targeted product recalls
Serialisation serves the internal needs of such companies’ food safety management systems, with the ability to trace back to source raw materials and ingredients to identify the point of failure. This has proven highly effective in safety-critical markets, such as Australia’s powdered milk industry and also in Canada’s fresh vegetable produce sector. Through the practical application of the GS1 standard, food and drinks producers are finding imaginative possibilities for direct consumer engagement, from providing environmental sustainability and animal welfare information to opening up marketing opportunities.
What other industry sectors maybe taken down the mass serialization path as regulators start to impose more stringent control ? Nutraceuticals, Botanicals, Acellular agriculture, or cannabis based products !
Accelerate and simplify your serialisation journey
Produmex specialists have a wealth of regulated industry expertise, working across different nodes of the supply chain including retail, wholesale distribution, third party logistic providers and manufacturing.
We can help you connect to supply chain partners, nation-specific NMVS and product verification applications, and integrate your ERP with warehouse management solutions, enabling you to trade in an efficient and compliant manner within the pharma network.
Related articles ‘Serialisation in the food industry: outsmarting the copycats’
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