Supply chains are disrupted, operations shutdown and businesses around the world are working out of home offices. Challenged by an array of unprecedented circumstances, pharmaceutical manufacturers are perhaps facing the greatest burden during this pandemic.
Like all companies, pharmaceutical suppliers are restricted in how they operate under the “new norm,” but must still ensure life-saving medications are safely and rapidly available to those in need. And that’s not to mention the massive demand and resulting mad dash to roll out potential vaccines and new treatments to combat the spread of COVID-19. The goal, of course, is always to keep people healthy and safe.
In this regard, labeling should not be overlooked, and in fact, plays a more critical role than ever before. It is an essential tool to ensure patient safety and pharmaceutical supply chain traceability. It should also never be a barrier to ensuring accurately packaged goods reach those who need them as fast as possible. So why do so many companies have a labeling problem, and what can we do to fix it?
The need for efficiency
Though labeling is critical to the accuracy and efficiency of pharma industry supply chains, the fact of the matter is many pharmaceutical manufacturers have limited central oversight and control over their labeling. For years, companies have used legacy label design and print solutions that are disparate across an organization or supply chain, and not specifically designed to holistically manage the entire labeling process. The end result is a lack of labeling harmonization that can seriously hinder supply chains at the production level.
To improve on manual processes, many companies have implemented semi-automated systems that focus only on certain components of the production line, but do not fully integrate processes across their operations. Often, this results in a patchwork of unstandardized practices and manual workarounds such as paper-based quality assurance processes or “sneakernet” practices, where data is physically transferred via a removable media like USB drives instead of on a centralized location over the network.
Additionally, these solutions segregate processes like serialization and aggregation, limiting the ability to track and trace items as effectively as possible and delaying process improvements by requiring extra print verification on production lines themselves.
Unfortunately, these types of inefficiencies quickly stack up, which leads to higher costs and slower turnaround times and ultimately delays critical pharmaceuticals from reaching consumers in need.
The danger of not adopting a standardized labeling system
While delays in the supply chain can be detrimental, a slew of other issues can also arise when using traditional and dated methods of labeling. For instance, as more human interaction is required, there’s also a greater chance for human error, which can result in anything from mislabeled products to a massive recall. The antidepressant Mirtazapine, for example, was recently recalled because bottles labeled 7.5 milligram may have contained 15 mg tablets — putting both the manufacturer and consumer at risk. While this type of error is deadly enough, the fallout from mislabeling a pharmaceutical during a hectic crisis could be catastrophic.
To help companies prevent recalls and improve operations, while getting much needed medications to their destination as quickly as possible, I’ve outlined common migration pain points when moving to a modern label management system, what to look for in a modern system, and best practices all organizations should follow to streamline labeling.
Migration pain points
Serialization and aggregation: Pharmaceutical manufacturers have had to comply with regulations around serialization for some time, but many countries are beginning to implement new rules around aggregation — keeping records of all the serial numbers and the relationships between them. Beyond compliance, aggregation also plays a pivotal role in improving supply chain visibility, providing a clear line of sight without having to take the time to unpack pallets and boxes as they move between manufacturers, wholesalers and retailers.
Every label variant that must be printed at an aggregation station needs to be test printed and verified. Today this is predominantly done on the production line, if there is no centralized system in place. Further complicating matters, the line cannot run during this process.
Dislocated networks and printing problems: Older or custom systems often only support specific types of label or marking printers — this is a big problem when different facilities use printers from different manufacturers. It’s also common for facilities to use completely different labeling software for serialization and aggregation. This can quickly result in compatibility issues, major roadblocks and incurred costs.
Legacy sprawl: The adoption of different labeling applications across facilities leads to inconsistent label formatting and the need to create the same label multiple times. Additionally, IT may have to hard code label designs and changes, user training becomes increasingly complex, printer integrations may have to be carried out by subcontractors at the local level, and more manual processes and human intervention become necessary for labels to comply with standards. All of this is costly, and equally important, exposes organizations to more potential labeling errors.
A modern approach to pharma labeling
Clearly, there are a slew of challenges and a growing need to harmonize labeling today, but there is always a feasible path to address an organization’s unique requirements. While there is no one-size-fits-all solution, here are some best practices any organization can follow to improve labeling processes.
Ensure agility in the face of changing regulation: Today’s shifting landscape requires the ability to rapidly adjust, and readjust, to comply with changing regulations or customer requirements. This is one area where a harmonized approach to labeling can be highly beneficial. Audit trails can be easily followed in a detailed, searchable record that indicates where and by whom a label was originated, changed and printed while data entry and quality control processes can be automated and customized for customers. This reduces risks of recalls from human error and minimizes duplicate efforts. All these improvements streamline the supply chain and prevent unwanted hazards, especially in times of crisis.
Support flexibility with an easy-to-integrate solution: Both label printers and thermal inkjet printers can be seamlessly integrated with any business system. This means supporting automated printing workflows, while remaining printer agnostic across all locations. This will reduce the need to replace hardware and will future-proof the environment to welcome mobile and IoT devices. Printing should also fit seamlessly in, and scale alongside systems like MES, ERP and WMS.
One system for serialization and aggregation: An organization must be able to govern a product’s labels as it moves throughout the entire supply chain, including serialization, where FDA compliant individual unique identifier labels are printed and verified often at rapid speeds using thermal inkjet printers, and on to aggregation, where boxes and pallets are labeled with thermal transfer printers before being shipped.
In this regard, a modern label management system should integrate with serialization and aggregation systems. It should decouple the layout from the production line set-up and handle the design and verification process offline. It should also digitize label approval workflows and automate the deployment of the right layouts for the right products to the lines. A modern label management system should consolidate universal label templates, and label layouts should not require hard-coded printer specific template files for serialization or aggregations systems.
In summary, a label management system should make packaging and aggregation labeling easier for manufacturers, eliminate the need to set up label designs after hours, and require fewer verification runs on the production lines altogether. This not only helps organizations meet regulatory requirements around aggregation, but it can also dramatically increase efficiency. Contract Manufacturing Organizations (CMO) are implementing such systems ahead of regulatory requirements to differentiate and gain a competitive advantage from their competitors.
Reduce IT burden: IT teams are often overtaxed. To make sure labeling does not overburden IT with tasks like hard coding templates or cumbersome change requests, a label management system should enable IT or authorized business users to quickly design or alter complex labels for any printer or model in a matter of minutes, without coding. This frees IT resources and speeds up time-to-market.
Enable remote work: Perhaps more than ever before, cloud-based solutions have become a critical success factor to maintaining business continuity. With a cloud-based labeling platform, workers do not have to go on site to design, update or troubleshoot labels, as any authorized remote user can quickly access a central hub to change and print labels from anywhere at any location. Not only does this enable remote work and label management from any location, it also promotes supply chain consistency while improving traceability and quality assurance.
Going beyond efficiency
Disaster can strike at any moment, but this doesn’t mean you can’t be prepared. Before choosing your next label management solution, consider what matters most for your business. What challenges are you currently facing, and what are your potential needs for the future? The right label management will not only enhance your operations today but can also prepare you for whatever challenges arise tomorrow.