Top trends in enterprise labeling: Part 2
4. Technology advances influence labeling
Technology continues to revolutionize the way companies conduct business and execute bus...
4. Technology advances influence labeling
Technology continues to revolutionize the way companies conduct business and execute business processes. Cloud-based computing offers endless possibilities for outsourcing applications and computing infrastructure, enabling companies to concentrate on core competencies. These new deployment models impact many aspects of business including labeling. As people continue to think differently about how applications will be delivered, they are at the same time beginning to think differently about how labeling is incorporated into these emerging deployment models. Companies are looking for their labeling solutions to embrace these new models from an access, integration, and deployment perspective.
Three important considerations behind this trend are:
- Accessing browser-based labeling: Companies seeking global deployment for labeling are utilizing browser-based applications, which can dramatically reduce the burden of installing and maintaining labeling systems. These applications allow companies to enable users with instant access to functionality, and provide security over labeling visibility and access, all while offering streamlined management of global operations.
- Implementing cloud-based technology: Many companies are moving their IT infrastructures to the Cloud to streamline their on-demand provisioning of software, hardware, and data as a service. Companies are either looking to integrate labeling with existing Cloud-based systems or for solutions that can be part of the adoption of this deployment model. The Cloud model provides flexibility to scale, eliminates the need for extensive disaster recovery plans and provides automatic software updates. Business users embracing this new technology will need labeling solutions to work with and potentially be deployed in the Cloud.
- Labeling meets the Internet of Things (IoT): A growing trend across multiple industries, IoT impacts how businesses communicate and connect. The opportunity to monitor and manage an entire network of devices, sensors, and other components provides untapped opportunities for a wide range of solutions including labeling. Labeling is an important component that needs to be considered as businesses evaluate their IoT strategy. As companies are implementing their IoT initiatives they are looking to rely on their labeling solutions to manage global printer networks, update device settings, send print requests and monitor status.
5. Evolving global regulations continue to impact labeling
The effect of regulations and emerging standards continue to impact businesses globally across a wide range of industries. Labeling is a specific area where constant change is necessary to comply with evolving requirements. More often than ever companies are looking for solutions that will assist them in achieving compliance in order to avoid fines, disruptions to their supply chains and ultimately loss of business. The GHS (Global Harmonized Systems) for Chemical Industry, the Drug Quality Security Act (DQSA) and the Unique Device Identification (UDI) for Pharmaceutical and Medical Device Industries, and the Food & Beverage Industry’s EU1169, as well as GS1 standards, are all having a significant impact on labeling.
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Here is a glimpse at some of the leading regulations and standards that are shaping the future of labeling in today’s global supply chain.
GS1 – The GS1 system of standards continues to play a significant role in food and beverage, health care and retail industries among others. GS1 provides standards for providing accurate identification and communication of information regarding products, assets, services and locations in the global supply chain. These standards, including barcode and ID Key Standards, offer implementation tools for traceability throughout the global supply chain. This includes Global Trade Identification Numbers (GTIN) and Global Location Number (GLN) allocation rules for use in barcode labeling to support safety initiatives and enable quick and efficient product recalls.
GHS – The GHS, which continues to impact business in chemical and related industries internationally, is a system for standardizing and harmonizing the classification and labeling of chemicals. From raw materials to finished goods delivery, companies are facing more complexity in chemical labeling with risk of heavy penalties for non-compliance. With the fast approaching deadline of June 2015, the GHS requirement is becoming a pressing consideration for chemical companies and many manufacturers, where all hazardous materials being housed, shipped or received, require proper labeling to abide by the ensuing GHS standard.
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DQSA / DSCSA – Part of the U.S. Food and Drug Administration’s (FDA) DQSA, the Drug Supply Chain Security Act (DSCSA), supersedes previous state level laws and addresses national track and trace of certain prescription drugs to play an important role with labeling in the pharmaceutical industry. Signed into law in 2013, the implementation is phased over ten years with several key requirements beginning at various stages in 2015. By 2023, the system will facilitate the exchange of information at the individual package level regarding where the drug has been in the supply chain.
UDI – Phased in over several years, UDI, which requires most medical devices distributed in the United States to carry a unique device identifier, continues to play a significant role with labeling in this industry. This mandate, which was adopted in 2014, is intended to improve patient safety and allows traceability of medical devices from production down to medical use. The next UDI deadline of September 2015 requires that all labels and packages for implantable, life-supporting, and life-sustaining devices bear a UDI and be submitted to the Global Unique Device Identification Database (GUIDID).
EU1169 – This European Commission standard, which increases the amount of mandatory information required to sell food products, represents a significant change to what and how information is displayed on food and beverage packaging. This rule, which was designed to make food labeling easier to understand, went into effect in December 2014 and ensuing requirements to include nutritional information will begin on December 2016. Although initiated as a European Union (EU) standard, this directive is far-reaching and impacts suppliers, food service operators, retailers and food business operators at all stages of the food supply chain within Europe and any global suppliers who import or distribute to Europe.
RoHS – The Restriction of Hazardous Substances (RoHS) Directive, which originated in Europe, restricts the use of six hazardous materials found in varied electrical and electronic equipment. Initiated in 2006, the mandate includes RoHS2, which proposes changes to the original directive, with proposed compliance dates for inclusion beginning in 2015.
About the author: Josh Roffman is Vice President of Marketing and Product Management at Loftware, a global market leader in Enterprise Labeling Solutions. Josh has over 20 years of marketing and product management experience with leading enterprise software companies. Specializing in the impact of supply chain trends on enterprise labeling, Josh frequently speaks at industry events most recently addressing attendees at Oracle’s Value Chain Summit, Pharma Labeling Conference, and the ASUG Fall Focus.
The challenges to vaccine distribution affecting everyone
While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined.
Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.
Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short.
Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification.
The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.
It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.
It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.
For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.
The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.
Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.
Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.
Disconnected information systems
While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration.
A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.
By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.
Political influence and social equality
As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.
In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.
However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.
Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution.
The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.