Vaccine supply chains are fast-moving, complex and critical to society, nowhere more so than in Covid-19.
While much attention has been paid 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: labelling.
think about it. Before vaccines are distributed, each label must be pre-approved based on key information such as warnings, directions and other prevention data.and every time Food and Drug Administration Changes in global regulations or customer requirements—whether it’s renaming a vaccine, approval for a new age group, disclosure of new potential side effects, or booster shots—labeling must also change.
I say now is the time for us to give labels the recognition they deserve, as organizations of all sizes can benefit from taking a closer look at their own labeling practices and how modern technology can improve their operations and supply chains.
To better understand how much impact a small label can have, we must first consider the unique challenges that vaccine supply chains face today.
Unique Challenges and Needs of Vaccine Labeling
While labelling plays a key role in any supply chain, many of the challenges facing the vaccine supply chain will only get worse when it is distributed globally. Here are just some of the factors to consider as they become increasingly relevant in the response to Covid-19:
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- Label content and regulations change rapidly: Each country, customer and brand has unique regulations, specific mandatory information and approval processes that require countless label changes – all of which are constantly changing.
- redistribute to other countries: Since vaccines are shared across borders, they must be quickly relabeled. This requires over- or late-labeling, and any errors or inconsistencies can lead to slowdowns, recalls, or worse.
- Preprint Delay: Many vaccine manufacturers and co-packers rely on inventories of labels pre-printed with product information, doses and other data. If an update is required, this means a delay. This can be a major issue when speed is an important consideration.
- Cold chain and unique handling requirements: Refrigeration requirements mean that any label-based delays in manufacturing facilities, warehouses, shipping containers and healthcare facilities can lead to spoilage. This relevant information must also be clearly identified by labelling to ensure proper handling and care.
- Track and Trace Imperative: From trays to individual unit dose labels, the most important thing is to ensure a clear and complete picture of where, where and when the vaccine is. This insight is critical to protecting patients — especially in the event of a recall — and can even help validate evidence of vaccination. It is also critical to prevent unauthorized counterfeiting, tampering and grey market vaccine distribution and the ever-increasing requirements that companies must follow to prevent this.
Of course, meeting these challenges has become more difficult, and outdated labeling methods are holding organizations back.
The problem with outdated legacy labels
With vaccine labels, there is a network of pharmaceutical companies, subcontractors, and other companies that must create, print, and distribute appropriate labels, sub-inserts, and other required informational materials. In this network, big brands may design compliant labels with critical information, but they may rely on numerous secondary facilities and third parties that need to package and distribute vaccines to their exact standards. This means that the ability to quickly share information with different facilities and suppliers is critical.
Urgency aside, rapidly changing vaccine needs mean that features such as on-demand label creation can be the difference between a successful vaccine launch or a discarded batch. In today’s fast-moving global supply chains, traditional methods such as pre-printed label inventory can be too slow and unreliable.
Manual and different labeling practices are also a very common problem with labeling vaccines. Different production facilities and distribution centers often manage labels individually using different software applications, manually entered data, or changing “on-demand” solutions.
Siloed processes make it harder to scale operations, increase the cost of supporting multiple applications, and delay responding to changing regulations and customer requirements. And, more importantly, siloed workflows also increase the risk of non-compliance fines and consumer health risks if products are mislabeled.
Additionally, when labels are not organized in a holistic manner, it can be difficult for all interested parties to access the same consistent, approved label content. Or it can be difficult to easily extend labeling information to suppliers, which can lead to delays and wasted vaccines.
In today’s world of rapidly growing data, developing a single source of truth should be part of every organization’s approach to label management. However, labelling issues, such as incorrect or missing data, often arise when manufacturers in different locations have to maintain different labeling solutions. These disparate solutions may fail to connect to ensure the accuracy of critical data, which could quickly lead to danger during vaccine distribution.
Ensure speed, agility and flexibility with enterprise labels
Labels are not just labels on vials, they must be considered from a multi-faceted, holistic perspective. After all, if labels contain inaccurate information or data, the consequences can be catastrophic, from hefty fines and financial losses, to recalls that endanger public health and safety.
Ensuring that tags are efficient and secure requires the coordination of disparate locations and organizations, as well as the various data sources that must be synchronized. Additionally, labels on vials, cartons, or other parts of vaccine packaging may need to be labeled in several different media, such as peel-off, direct labeling, and a host of other media. Various labels may also need to be updated quickly if new contraindications, allergic reactions, or other safety concerns are discovered throughout clinical trials or after vaccine distribution.
To ensure interconnectivity and a single source of truth, enterprise labels enable organizations to standardize and integrate labels with business processes and labels across lines of business and geographies. Therefore, with the right solution, labels can be easily integrated with business applications such as Manufacturing Execution (MES), Enterprise Resource Planning (ERP) or Product Lifecycle Management (PLM) systems.
Once labels are integrated with an enterprise’s proven data sources, label manufacturers can gain many advantages, such as the ability to predict new label changes based on early clinical trials, or the ability to quickly integrate feedback on vaccines issued under emergency authorization. These features speed the creation of essential updates, such as temperature-related expiration dates, dosage information, side effect warnings, or other data that must be quickly applied to future labels.
Once these updates are made in an enterprise tagging solution, organizations can ensure that everyone has secure access to the same updated tagging data and reliable tracking. Enterprise labels can also enable advanced logic, automation, and other features to instantly ensure the latest information is widely available across different labels. Additionally, business users can help quickly design or update labels for any printer or model without coding. This eases the burden on IT and reduces bottlenecks.
The value of cloud-based solutions
One of the best ways to deploy an enterprise labeling system or extend it to partners is to use a cloud-based solution. With cloud-based tags, organizations can quickly connect new sites with an enterprise’s corporate data and brand appearance, as well as related product and customer information. This means that if vaccine manufacturers work with third-party suppliers, they can easily extend compliant, controlled labelling into their operations for seamless remote collaboration. Or, if another location is closed or must be quarantined, organizations can quickly expand the label to the new location.
By using a cloud-based enterprise labeling solution, users can also collaborate more efficiently and benefit from on-demand and remote printing capabilities, regardless of geography. This eliminates the additional costs and delays associated with regularly shipping pre-printed labels to remote sites.
Upgrade for the future
By breaking down siloed processes and addressing label management issues enterprise-wide, organizations can ensure that vaccine labels are often accessible and accurate, and that label data has a single source of truth. In addition, enterprise labeling can also prepare organizations for future crises by making it easier to extend appropriate labeling data to different locations and partners.
As the world moves forward and supply chains become more globalized, as the regulations surrounding it become more complex, label modernization will only become more urgent. If there’s one thing we’ve learned from Covid-19, it’s that disruptions can happen in the blink of an eye, and ensuring supply chain resiliency requires planning ahead — not just for today’s challenges, but for tomorrow.
So if your supply chain doesn’t include corporate labels now, can you really wait until the next crisis escalates?
