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March 21, 2022


The Critical Role of Labeling in the Vaccine Supply Chain

by Laura Johnson

While a great deal of attention has been given to streamlining supply chains – and ensuring vaccines reach healthcare providers and their patients around the world – one of the most critical components is also the most overlooked: the label.  

Before a vaccine can be distributed, every label must be pre-approved based on critical info like warnings, instructions, and other precautionary data. And every time the FDA and global regulations or customer requirements change – whether it’s renaming a vaccine, approving use for a new age group, disclosing new potential side effects, or the issuing of booster shots – the label must change as well. 

Vaccine manufacturers of all sizes can benefit from taking a closer look at their labeling practices and how modern technologies can improve their operations and supply chains.  

The Unique Challenges and Demands for Vaccine Labeling  

 While labels play a pivotal role in the supply chain, there are many challenges vaccine supply chains face that become amplified when distributing on a global scale. Here are just a few to consider:   

  • Label content and regulations change rapidly: Every country, customer, and brand has unique regulations, specific mandated information, and approval processes, requiring countless label variations.   
  • Redistributing to other countries: As vaccines are shared across borders, they must be rapidly relabeled. Any errors or inconsistencies can lead to slowdowns, recalls, or worse.   
  • Delays from pre-printing: Many vaccine manufacturers and co-packers rely on pre-printed label stock. This means delays if an update is needed.  
  • Cold chain & unique handling requirements: Cold storage requirements mean any label-based delays can result in spoilage. This information must also be clearly identified via the label to ensure proper handling and care.  
  • Track and trace is imperative: From pallets down to individual unit-dose labels, it is important to ensure complete visibility into where vaccines have been, where they are going, and at what time. This insight is essential for protecting patients – especially if a recall occurs – and could even help to verify proof of vaccination.  It is also vital to prevent counterfeiting as well as address the growing requirements companies must follow to prevent it.  

Addressing these challenges becomes much more difficult with legacy approaches to labeling.   

 The Problem with Dated, Legacy Labeling  

 With vaccine labels you have a network of parties involved; all of whom must have access to approved labels, inserts, and other informational materials. This means you’ll need the ability to share information with different facilities and suppliers quickly. 

 Adding to the urgency, fast-changing vaccine requirements mean capabilities like on-demand label creation can be the difference between a successful vaccine rollout or a discarded batch. Legacy approaches, like pre-printing label stock, can be too slow and unreliable in today’s fast-moving, global supply chains.  

 Manual and disparate labeling practices are also a common problem for labeling vaccines. Different production facilities and distribution centers often manage labeling in isolation, with different software applications, manually inputted data or continuously changing “as-needed” solutions.  All too often, labeling issues, like incorrect or missing data, occur when manufacturers in different locations must maintain varying labeling solutions. These disparate solutions might not have connectivity to ensure key data is accurate, and this can quickly lead to a hazard during vaccine distribution.   

 Siloed processes make scaling operations harder, add costs to support multiple applications, and delay responses to changing regulations and customer requirements. And, more critically, siloed workflows also increase the risks of non-compliance fines and consumer health dangers if products are mislabeled.   

Ensuring Speed, Agility, and Flexibility with Enterprise Labeling  

Ensuring safe and efficient labeling requires coordinating different locations, organizations, and a variety of data sources. Additionally, labeling on vials, cartons, or other parts of a vaccine’s packaging may need to be featured in several different mediums, such as peel-offs, direct marking, and a plethora of others. Rapid updates to the various labels may also be needed if new contraindications, allergic reactions, or other safety issues are found.   

 To ensure interconnectedness and a single source of truth, Enterprise Labeling enables organizations to standardize and integrate labeling with business processes and across geographies. Labeling can be easily integrated with business applications, like a manufacturing execution (MES), enterprise resource planning (ERP), or product lifecycle management (PLM) system.  

 Once labeling is integrated with an enterprise’s verified data sources, organizations can anticipate new label changes based on early clinical trials or the ability to rapidly incorporate feedback from vaccines that were sent out under emergency authorizations. These capabilities speed the creation of essential updates, such as temperature-dependent expiry dates, dosage info, side effects warnings, or other data that must be rapidly applied to future labels.    

 Once these updates are made in an Enterprise Labeling solution, organizations can ensure the same updated label data is accessed securely and tracked reliably. Enterprise Labeling can also enable advanced logic, automation, and other features to instantly ensure the most updated information is available for different labels. Additionally, business users can quickly design or update labels for any printer or model, without coding. This unburdens IT and reduces bottlenecks.  

 The Value of Cloud-Based Solutions  

 One of the best methods of deploying an Enterprise Labeling system or extending it to partners is to use a cloud-based solution. With cloud-based labeling, organizations can quickly connect a new site with corporate data and pertinent product and client information. This means if a vaccine manufacturer is working with a third-party supplier, they could readily extend compliant, controlled labeling to their operations for seamless remote collaboration. Or, organizations could extend labeling quickly to a new location if another is shut down or must be quarantined.   

 By using a cloud-based Enterprise Labeling solution, users can also collaborate much more effectively and benefit from on-demand and remote printing capabilities, regardless of geography. This eliminates extra costs and delays associated with regularly shipping pre-printed labels to remote sites.  

 Upgrading for the Future  

 By breaking down siloed processes and addressing label management on an enterprise-wide level, organizations can ensure vaccine labels are accessible and accurate, with a source of truth for label data. Additionally, Enterprise Labeling can also prepare organizations for future crises by making it easier to scale and extend the proper label data to different locations and partners.   

 As the world moves forward and supply chains become increasingly global, modernizing labeling will only become more imperative as the regulations around it become more complex. If there’s one thing we’ve learned from COVID-19, it’s that disruption can happen in the blink of an eye, and ensuring supply chain resiliency requires planning ahead – not just for the challenges of today, but also for tomorrow.  To learn more, visit our pharmaceutical labeling web page.  

* This article was first published in MedCity News.