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Laura Johnson, Loftware, Senior Director of Sales, Life Sciences, discusses the importance of the right label.
Recent years have shed light on the importance of acting with speed and agility when developing and delivering pharmaceutical products. The expedited trial procedures for the COVID-19 vaccine underscored the necessity for proactivity and collaboration throughout the supply chain. The urgency of the pandemic prompted regulatory agencies, pharmaceutical companies, research institutions, and manufacturers to work collaboratively and often in ways that hadn’t been previously explored. Medical trials were streamlined whilst rigorous safety and scientific standards were maintained.
In this way, the pandemic highlighted the importance of maintaining communication and information throughout the pharmaceutical supply chain. From raw material suppliers to manufacturers, down to distribution networks, each aspect of the supply chain had to adapt rapidly to meet demand for the COVID-19 vaccine rollout. In fact, the pandemic expedited the progression of trends already underway in the pharmaceutical industry, notably the implementation of critical digital methods such as the cloud.
Often overlooked, a drug’s packaging and label are essential for the seamless transportation of any product. Cloud-based labelling solutions provide crucial delivery information, enable greater visibility, ensure regulatory compliance, and reduce the likelihood of costly recalls. For the pharmaceutical sector, where patient wellbeing and treatment efficacy are core priorities, packaging and the label assume an even greater level of importance, safeguarding handlers as well as the end consumer.
Navigating a Complex Regulatory Landscape
The accuracy and clarity of pharmaceutical products rightly faces much attention. The sector, already heavily regulated, has recently seen a raft of changes across the globe, including the EU’s False Medicines Directive, Brazil’s implementation of the National Medicine Control System, and the FDA’s updated Code of Federal Regulation.
Looking ahead, the sector can anticipate further regulations. For example, the US Drug Supply Chain Security Act, which aims to create an electronic traceable supply chain to prevent the entrance of counterfeit and fake medication, is set to be implemented in November 2023. Earlier this year, the European Parliament granted an extension to the European Union’s Medical Device Regulation (EU MDR), now set to be implemented in 2027. These evolving regulations can be burdensome for manufacturers, presenting additional risks and costs. Unsurprisingly, Loftware’s recent ‘2023 Top 5 Trends in Labelling and Packaging Artwork’ report revealed that 84% of business leaders consider today’s regulatory demands to be more complex than ever before.
The label assumes a pivotal role for pharmaceutical companies who must adhere to current and future regulations. By adopting a centralised cloud-based labelling solution, pharmaceutical companies can manage and update labels, collaborate with stakeholders, and access real-time data from anywhere and at any time. This not only improves the speed, accuracy, and efficiency of drug delivery and packaging processes, but also gives manufacturers access to the necessary data to meet the diverse set of regulations across jurisdictions. The real-time monitoring, next-level security measures, seamless scalability, and enhanced collaboration capabilities enabled by cloud-based systems further simplifies and automates the process, thereby enabling manufacturers to focus on other core operations.
Importance of Traceability
Visibility throughout the supply chain is vital and for the pharmaceutical industry, the stakes are high. Technological advancements now mean it’s possible to trace products both upstream and downstream with greater ease. The label, which carries important product information such as serial numbers, certificates of origin, and batch information, establishes a vital link between the digital and physical aspects of the product. In essence the label enables a complete audit trail from raw ingredients to manufacturing and distribution to the end-user, thereby helping to remove counterfeit drugs from the supply chain, ensure patient safety, and safeguard brand reputation.
By enhancing their label management with cloud technology, pharmaceutical companies can improve quality control, better mitigate risk, and avoid unnecessary recalls resulting from label and print errors.
Future-proofing Pharmaceutical Manufacturing
The pharmaceutical industry's response to recent challenges underscores the vital importance of agility, collaboration, and adherence to evolving regulations. The expedited development of the COVID-19 vaccine highlighted the critical role of effective supply chain communication and adaptation, with cloud-based labelling solutions emerging as a key driver of streamlined processes and enhanced compliance. The integration of this technology not only ensures regulatory adherence but also strengthens efficiency, patient safety, and brand reputation. As the industry continues to navigate a complex regulatory landscape, embracing innovative solutions like cloud-based labelling will become paramount, allowing pharmaceutical companies to forge a resilient path toward a secure and successful future.