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5 Aspects of Russian Pharma Compliance You Should Know Right Now

Whether you manufacture medical products in Russia or plan on importing them into the country, you need to understand the regulations for pharma compliance that will go into effect in January 2020. Here are the five most important aspects to consider.

1. Deadlines for Product Serialization

Under the new regulations, the deadline for serialization for products manufactured in Russia or imported into the country is December 31, 2019. Other regulations that came into effect at the end of 2018 called for serialization of products on the Essential Drugs List and “Seven Nosologies,” a state program that helps patients access high-cost treatments for orphan diseases (i.e., rare diseases).

2. Tracking and Reporting Compliance Events

Russian pharma compliance stipulates that all foreign pharmaceutical manufacturers and distributors must track and report up to 36 compliance events. This is a much higher standard than other regulations, including the EU’s Falsified Medicines Directive (FMD), which requires seven compliance events, and the Drug Supply Chain Security Act (DSCSA) in the United States.

Foreign manufacturers and distributors must track a wide range of product transactions and movements, as well as packaging changes, and report to Russia’s Federal State Information System for Monitoring Drug Circulation via XML uploads with electronic signatures. These reports must be submitted within five business days.

3. Reporting Requirements

The new reporting requirements differ depending on the business type and model. The business use case dictates the type of compliance events to track and report, as well as different sequences of those events.

4. Prescription and OTC Products Requirements

The new regulations dictate the tracking and tracing of both prescription drugs and over-the-counter (OTC) products. This is unlike EU and U.S. regulations, which cover only prescription drugs and high-value medicines.

This is a challenge for EU and U.S. pharma companies that are either in the process of storing their product master data or that have already finished compiling it. If these companies want to distribute in Russia, they now also have to source their product master data for OTC products.

Furthermore, pharma companies in the EU or United States that want to do business in Russia have to make sure they serialize their products to meet the pharma compliance deadlines. All their manufacturing lines must include OTC product serialization.

5. Aggregation Requirements

FMD and DSCSA compliance regulations do not have aggregation requirements. Russian pharma compliance, however, will require documenting and reporting aggregation. In other words, all aggregation and disaggregation operations are considered compliance factors. Furthermore, every serial number for medicines in Russia must contain a unique identifier. This is an extra layer of security against counterfeit drugs entering the supply chain.

 

These are the most notable facets of the Russian compliance regulations that foreign companies must keep in mind as 2020 approaches. rfxcel’s Traceability Platform (rTS) can help you properly keep track of all the products in your supply chain. If you want to ensure you’ll be fully compliant with the new Russian regulations, contact us for more information. Our supply chain experts, including staff in Russia, are ready to help!

Track and Trace and the Importance of Order Fulfillment in Pharma

The health care supply chain and the pharmaceutical industry have realized great benefits from track and trace, product serialization, and related requirements in the U.S. Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA). For example, manufacturers, repackagers, and wholesale distributors can now verify all the products they sell and receive, and guarantee there are no counterfeit drugs on the market.

But what makes that possible? How can they track and trace all the products in the pharmaceutical supply chain?

What Does Track and Trace Mean in Pharma?

Track and trace enables pharmaceutical manufacturers, repackagers, and wholesale distributors to follow products through the entire supply chain. Using traceability platforms, they can track their products at the individual unit level, enabling them to verify every product and instantly identify problems, such as a potential counterfeit drug or environmental excursions. This revolutionary solution will significantly improve order fulfillment and transform the entire health care supply chain.

Serialization is the key to track and trace. Serialization is the process of assigning unique two-dimensional (2D) bar codes to each product (i.e., at the unit level). Today, it’s common for companies to store the codes in a secure cloud. Blockchain, a distributed-ledger technology, has garnered some interest but has yet to be widely adopted in pharma supply chain operations.

Why Is Order Fulfillment So Important?

Imperfect order fulfillment leads to lost revenue — even damage to a brand’s reputation — because delayed or incomplete orders negatively affect customer experience.

Suppliers with delayed orders can even face hefty fines from the retailers who distribute their products. If you don’t want to incur penalties or risk losing customers, you need to make sure you always fulfill your orders accurately and on time.

Track and trace solutions have an advantage here because they provide end-to-end visibility of the entire pharmaceutical supply chain. In other words, every single product can be traced. Retailers can proactively monitor goods in real time (e.g., locations of their orders and how they are being processed) and make sure there are no discrepancies or failed transactions.

Such proactive monitoring enables predictive visibility, which helps satisfy all customers. It makes the ordering process much smoother, shortens order-to-delivery cycles, reduces out-of-stock rates, and helps increase revenue.

The conclusion is that track and trace, teamed with product serialization, drives business value. And not only in pharma, but virtually any industry that operates a supply chain. By increasing  visibility and enabling real-time monitoring, it helps optimize inventory, fulfill orders, speed and simplify returns and recalls, increase revenues, and improve brand loyalty.

If you are seeking a superior track and trace solution, contact the rfxcel team. The most tenured track and trace company in the life sciences, rfxcel will help you optimize your operations no matter the circumstances (We even have a solution that enables you to connect to any blockchain.) From meeting all DSCSA compliance requirements and eliminating counterfeit drugs to building your brand reputation and increasing revenues, rfxcel has you covered.

Serialization & DSCSA Compliance

Several years ago, more than 500 manufacturers, distributors, and consultants met to discuss the issues in the US healthcare supply chain. This meeting would tackle the issue of counterfeit drugs in the supply chain and how to reduce their number.

This meeting introduced the idea of product serialization and discussed the need to enhance traceability in the healthcare supply chain. Here’s what all of this means.

What Is Product Serialization?

Product serialization is the unique identification of products, which goes down to the level of individual items, rather than only at the batch level. Serialization pharma is the identification of individual packs of medications, that is, assigning them a globally unique two-dimensional code, and marking it on the packaging.

With the implementation of product serialization, a proper system for tracking and tracing products in the entire supply chain must be integrated. That kind of a comprehensive system will enable US wholesalers to verify the products, as well as exchange data with other wholesalers in the supply chain.

This initiative is called DSCSA compliance, and every pharmaceutical manufacturer, re-packager and wholesale distributor in the US must adhere to the regulatory requirements. The mandated deadline was November 27, 2018.

What Is DSCSA Compliance?

DSCSA (Drug Supply Chain Security Act) compliance is the U.S. initiative to prevent the introduction and distribution of counterfeit drugs.

The main goal of this compliance is to enable pharmaceutical manufacturers, re-packagers, wholesale distributors, pharmacies, and third-party logistics to exchange information about every single medication package and see exactly where it has been in the supply chain.

This will help them verify the products, identify illegitimate products anywhere in the supply chain, and make recalls of drug products more efficient.

All of this is made possible with the introduction of blockchain technology. All of the product data will be stored in an open-source blockchain-based repository, which will be available to anyone in pharma who needs to track, trace, and verify the products in the supply chain.

How to Be DSCSA Compliant?

To be DSCSA compliant, every pharma business affected by the DSCSA compliance laws must capture transaction information (TI), transaction history (TH), and transaction statement (TS) from the previous owner, and provide it to the subsequent owner of each product.

They must maintain their TI, TH, and TS for every transaction for six years. They must only ship legitimate products, and they can never change the transaction history in any way.

Pharmaceutical serialization and traceability will modernize the pharma industry. The initiative will revolutionize the industry and, hopefully, eliminate all the counterfeit drugs from the supply chain.

If you need a reliable solution for tracking and tracing products in the healthcare supply chain, rfxcel is here for you. We can help you meet all the needs of product serialization and become DSCSA compliant in no time. Contact us today to find out more about how we can be of help.

Takeaways from the 2019 PMA Tech Knowledge Conference (Hint: It’s All about Food Supply Chain Data)

The Produce Marketing Association (PMA) held its annual Tech Knowledge conference May 1–2 in Monterrey, California. At this showcase for cutting-edge ag tech, experts discussed food supply chain data, the future of food production, and industry challenges.

This edition of rfxcel’s food and beverage blog takes a quick look at what some of the speakers said at Tech Knowledge 2019.

Joshua Katz, Partner, Agriculture and Strategy Practice, McKinsey & Company

Joshua said emerging technologies were disrupting industries, bringing rapid, large-scale change. He presented 12 “transformative technologies” that can improve the sustainability, efficiency, and health impacts of food systems by 2030. Examples are alternative proteins and biological-based crop protection, whose value chains account for one-third of disrupters. Joshua said disrupters included mobile tech, big data analytics, and Internet of Things (IoT) for real-time supply chain transparency and traceability.

Kenneth Scott Zuckerberg, Senior Vice President and Strategist, Wells Fargo

Ken, who focuses on food/agriculture, sustainability, and technology, talked about the convergence of farming, tech, and finance. He said that as farmers and agribusinesses adopted data-intensive tools, their systems would produce food more efficiently and thoughtfully. There will also be less waste and environmental impact. He said producers should focus on the bottom line, not yields, because it would result in less waste and more efficiency.

Vonnie Estes, Vice President, Technology, PMA

Vonnie discussed what companies need to do and know about new technology. She said we needed solutions, not technology products. The point of all this technology” is to improve profitability, performance, and simplicity for growers. Companies should use tech to develop durable, usable solutions. Tech should anticipate and meet consumers’ demands and preferences, including reducing food waste, improving labeling, and knowing “the story” of the food they buy. It should produce varied, nutrient-rich, and safe foods. Therefore, companies that want to survive and thrive must ask themselves two questions: What strategies do you have in place to innovate? What new tech do you think will disrupt your business?

Seana Day, Partner, Better Food Ventures and The Mixing Bowl

Seana talked about trends and investing in post-harvest, value-added food. She focused on “the messy middle” of the food supply chain. Investment here can really pay off, especially for reducing waste. Yearly food waste is staggering: 1.3 billion tons worth $1 trillion — and 80% of this occurs in the supply chain. She also discussed transparency. Calling it “the T word,” she said it was “fundamental to trust.” And though retailers are promising it and consumers want it, “Supply chain actors don’t always benefit from it.” This is an honest acknowledgement of one of the barriers to adoption. Seana agreed that food supply chain data and technology should do more than increase yields. In supply chains, tech can tackle food waste, monitor temperatures, manage inventory, and forecast with real-time, actionable data.

Ranveer Chandra Chief Scientist, Microsoft Azure Global

Ranveer talked about Microsoft’s efforts to significantly increase the world’s food production. The project he leads, FarmBeats, uses IoT technology such as low-cost sensors and the cloud to gather data from farms. He said that end-to-end food supply chain data, coupled with farmers’ knowledge and intuition, could increase productivity and reduce costs. Challenges include that many farms do not have internet connectivity or reliable sources of power. Furthermore, many farmers know little or nothing about technology. He said data-driven farming was the future of agriculture, and that FarmBeats is committed to making it the global norm.

Panel Discussion: Lessons Learned on Bringing New Tech to Food Supply Chains

Vonnie Estes moderated a wide-ranging discussion with iUNU CEO Adam Greenberg; Karol Aure-Flynn, vice president, sector analyst, and team lead at Wells Fargo’s Food and Agribusiness Industry Advisors; and Nolan Paul, partner and AgTech lead at Yamaha Motor Ventures.

The panel’s opinion of blockchain might have turned some heads. They were generally unimpressed, echoing what Subway’s Director of Supply Chain Traceability Lucelena Angarita told Forbes earlier this month: “Blockchain is not seen as a good fit at present for traceability.” Though Angarita was talking specifically about Subway, the world’s largest retail food chain, Adam, Karol, and Nolan suggested it was essentially true for the entire industry.

The panel’s overall message was clear: The food industry is transforming the way it produces food. Therefore, innovation and food supply chain data are key. From IoT and artificial intelligence to drones and bioengineering, technology will better predict outcomes, determine how farmers and producers are financed and insured, and enable a larger, safer, and more sustainable food supply chain.

Why the Modern Food Supply Chains Need Real-Time Environmental Monitoring

Food supply chains are becoming more complex, as food companies are increasingly faced with blind spots such as deviations from required environmental conditions, theft, fraud, and poor handling. Supply chains are global; transit routes that involve road, rail, sea, and air create many potential points of failure in food safety or product integrity protocol that, until recently, were largely outside a company’s control.  

To maintain product quality and safety, companies should implement an environmental monitoring (EM) solution that paints a complete picture of their food products as they move through the supply chainEM solutions that utilize devices powered by the Internet of Things (IoT) allow real-time tracking of cargo and provide actionable data that can mitigate common problems, change outcomes, and protect brands and consumer health.  

Let’s take a deeper look into the problems that food manufacturers and distributors are facing how EM solutions can minimize or eliminate them altogether. 

Current hurdles for food supply chains 

As the global network of food trade expands, the diverse challenges facing suppliers, manufacturers, distributors, and logistics companies present even more of a threat to supply chains and revenue.  

`Greg Quinn, worldwide food fraud results in losses of at least $65 billion a year. Luxury products such as Japanese Wagyu beef and Italian olive oil are regularly counterfeited and incorrectly labeled, and buyers often have no way to trace the origins of what they’re purchasing.  

Companies in the food and beverage industry also face diversion and theft, which can happen at any of the many blind spots along the supply chain. In fact, food and beverages were among the top commodities targeted by thieves in North America last yearaccounting for 34 percent of all cargo theft. 

Food product quality and safety are also seriously compromised when cargo is poorly handled while in transitwith hazards such as exposure to water, heat, and cold, or substance contamination. These types of damages can be particularly acute in the cold chain, where perishable products must be moved quickly under specific environmental conditions, including temperature, humidity, and light.  

Furthermore, inefficiencies in routing — from not adhering to transport regulations to more basic oversights such as not monitoring traffic or not utilizing GPS location tracking — delay shipments, can result in product spoilage and/or shortened shelf life, and cost companies moneyRouting and EM have become more important in light of government legislation, most notably the Food Safety Modernization Act (FSMA), which the U.S. Food and Drug Administration designed to better protect consumers by strengthening food safety systems for foodborne illnesses 

In short, businesses that manage food supply chains need to be on top of their game to guarantee product quality and safety and care for their brand. 

How does product tracking technology work in food supply chains? 

Real-time EM solutions are proving to be an invaluable asset for companies seeking to combat supply chain challenges. Such product tracking capabilities give companies a vibrant and detailed picture of where their products are and what is happening to them. With EM in the supply chain, IoT technology is the crucial link to continuity, visibility, and productivity.  

So, how does integrated EM work? Sensors on palletscases, or containers send data over communication networks at regular intervals. The data is made available via a software platform, where users can set parameters (e.g., minimum and maximum temperature) to alert the system of irregularities or generate reports for analysis. This data is associated with the traceability data and becomes part of a product’s pedigree, making it a powerful tool for supply chain visibility. 

EM combats supply chain stumbling blocks 

EM allows companies to monitor their food supply chains, protect consumers, and realize considerable return on investment. The technology can show companies how to maximize route efficiencies, change shippers, or detect theft or diversion in real time. Tracking solutions transmit alerts, empowering manufacturers and suppliers to use data to halt shipments that may have been adulterated, redirect shipments to extend shelf life, and manage food recalls — or avoid them altogetherRecalls are a particularly important consideration: One 2012 study concluded that the average direct cost of a recall in the United States was $10 million. 

The IoT-enabled technology provides real-time information about how long an item has been in transit, if the vehicle transporting it adhered to the approved route, and, if the shipment stoppedwhere and for how long. This is crucial information, especially for highly perishable goods. For example, leafy greens can be ruined if a truck’s engine and cooling system are turned off for hours at a border crossingWith EM and tracking, businesses are able to understand and act upon specific risks using detailed, unit-level data for their food supply chains. 

For example, a company can find out if pallets have dislodgedfallen, or have been compromised in other ways while in transit. They can receive alerts if the doors of truck are opened at an unscheduled time or location, which could indicate theftThieves target food cargo more often than other products because it’s valuable, easy to sell, and perishable, and evidence of the theft does not last very long. In fact, the U.S. Federal Bureau of Investigation estimates that cargo theft costs U.S. businesses $30 billion each year, with food and beverage one of the primary targets. Businesses need to get smart about preventative actions. 

All of this actionable data is available in real time, allowing businesses to make decisions immediately, not after the fact when it’s too lateWhen necessary, they can divert or reroute shipments or take actions to remedy temperature excursions and other environmental concerns. This saves money and protects their reputation. Furthermore, third-party logistics firms and contracted delivery companies can be held accountable for incidents and inefficiencies. 

Conclusion 

As the benefits of global supply chains have grown, so have the risks. With the FSMA shifting responsibility for safety to food companies, real-time EM is a vital step to ensure cargo is maintained in the correct conditions, remains on track to its destination, and is safeguarded from theft and fraudWith the advent of IoT-enabled tracking and EM technologies, supply chain operations can be streamlined and companies can prevent waste and financial losses, protect their investments and brand identity, and gain an advantage in the marketplace. 

About rfxcel  

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the USA and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region. 

About Todd: 

Sales Director for Food & Beverage @ rfxcel has been working with food & beverage companies to bring their food safety, supply chain visibility, and traceability initiatives to life for several years. As a former supply chain & logistics director for a CPG, Todd’s experience is unique in having been on both sides of strategic projects – from selecting to implementing and now offering enterpriselevel supply chain and traceability solutions. Additionally, Todd has a direct-to-consumer data background to help partners realize the full potential of protecting and growing their business. 

The Future of Food Safety Is Serialization

The Food Safety Modernization Act wants companies to proactively mitigate risk. Unit-level traceability is the logical next step

Leafy green producers had a terrible 2018.

According to the Centers for Disease Control and Prevention (CDC), E. coli outbreaks linked to romaine lettuce infected 272 people in 39 states and the District of Columbia; of these, 121 were hospitalized and 5 died.1 Outbreaks linked to romaine from the same growing area also occurred in Canada. There was one recall, and both countries issued an advisory for all romaine.

Apart from the human toll, the cost of recalls can be staggering. A 2012 study by the Grocery Manufacturers Association (GMA) and the Food Marketing Institute concluded that the average direct cost of a recall in the United States was $10 million. In a separate study, GMA reported that 18 percent of surveyed multinational corporations had spent $30-$90 million on a single recall, and 5 percent had been involved in recalls with price tags topping $100 million.

Factor in indirect costs such as legal fees and damage to brand reputations and product categories — even entire industries — and it’s easy to see that recalls are a major problem.

During the romaine outbreak, Dr. Bob Whitaker, chief scientific officer at the Produce Marketing Association, advised the leafy greens industry to “ready traceback data.” This was an admission that the food industry had a long way to go to meet the demands of the modern supply chain, where accurate, granular, real-time product data is essential for mitigating emergencies and remaining competitive.

End-to-end, serialized, unit-level traceability is now the standard in the life sciences industry, where, like the food industry, a product’s purity and authenticity can be a matter of life and death. Similarly, serialization has the potential to increase the speed and accuracy of food safety investigations while reducing the scope and cost of recalls and product withdrawals.

Today, we can imagine a world where each bag of lettuce mixes or clamshell of berries has a unique identifier that can be tracked and traced from the exact picker and harvest plot through packing, casing, and palletizing, then on through distribution and retail — all the way to the consumer.

We can also envision empowering consumers to know everything about the pedigree of the exact item in their hand. What if they could scan your item at the store to ensure that it isn’t involved in a recall? What if you could message them after they took it home? What if you could tell them the item they’re holding had been scanned for foreign objects or tested for contamination that same day?

At last year’s Food Safety Consortium in Chicago, representatives from the CDC and U.S. Food and Drug Administration, presented on 2018’s first romaine outbreak, which began in April and appeared to be over by late June. As reported by Food Safety Tech, they identified several challenges, including:

  • The production lot information disappears at the point of service.
  • Having a commingled product hinders traceback.
  • It takes time for authorities to review companies’ records.
  • Packaging isn’t transparent about where the product was grown.

Let’s walk through a scenario in which people report getting sick after eating romaine lettuce from packs they purchased at a retail store. With serialization, the chain of events could look like this:

  • Consumers who feel sick can report the package’s serial number by phone or perhaps through a link, sent by the retailer, that reads a 2D barcode and transmits the package’s unique number.
  • All products from that harvest plot are immediately flagged, as the traceback goes all the way to the pickers/plots, then forward again to the actual items on the shelf — not just to a distribution center.
  • With rich data from serialization, we know which items from the case are on the shelf and which are still in the case.
  • As more data becomes available, authorities can pinpoint the issue, and only affected items are pulled from the shelf.

The benefits of serialization are great and costs are coming down. Consumers are interacting more with brands and expecting more data about products. Recognizing these realities — and in the ever-present context of the Food Safety Modernization Act — food companies should be looking to serialization and unit-level traceability to provide the data to safeguard their operations and thrive in the marketplace, today and in the future.

1See CDC information from June 28, 2018, and January 9, 2019.

Orders of Magnitude: What Does Serialization Mean for the Food Supply Chain?

Serialization has transformed pharma. Food and beverage is next.

The pharmaceutical industry, spurred by global regulatory demands, has begun to transform itself by adopting unit-level traceability through serialization.

It has also responded to the ever-present threats of fraud, adulteration, and counterfeiting by working to make the supply chain a tightly controlled, transparent system. And, importantly, companies have begun to use the richer, timelier data that serialization creates to gain competitive advantages and increase market share.

The food industry is at a different type of crossroads, but it may lead to the same place. Innovative leaders are beginning to see serialization as a key tool to mitigate risk and drive growth; they are realizing that it empowers real-time track and trace and authentication, targeted product recalls, personalized marketing, and other critical operations.

But what is serialization, exactly? Simply put, it’s the process of creating a unique identifier or code for every item you sell, a package-level ID that can add up to four orders of magnitude (lot/batch, pallet, case, item) to your supply chain visibility in a single step. With serialization, each production batch is transformed from a jumble undifferentiated packs to individual, traceable units that have quality metrics and event attributes associated with their data. This data, from harvest information to each item’s unique journey to the consumer, is transparent and specific, not opaque and broad, which amplifies its power for decision-making, quality assurance, and a host of other uses.

The automotive industry, an early adopter of serialization, provides a nice analogy. Think of your car’s vehicle identification number (VIN). It is unique and trackable. When you buy a used car, you don’t use the VIN to learn about Ford Explorers generally; you use it to find out about the exact car you’re looking at — its history, its real-time condition, and so on.

This is the power of serialization. Knowing the unique story of the very item you’re holding in your hand. The idea that this clamshell of strawberries or container of tomatoes or can of soda may have a different story than the one next to it, even if they look identical.

In a lot-based system, the lot code provides only limited data. All the pallets, cases, and units share the same basic information, even if there are crucial differences among the individual items, such as the provenance of ingredients or harvest dates.

Product tracking can begin to fall apart as soon as shipments arrive at a distribution center. Pallets can be re-routed and cases can be disassembled and re-packed before units are shipped to fulfill orders.

With serialization, each input or movement can be recorded. When individual units are serialized, so are the case and pallet. Scanning the case or pallet provides data for all units inside and allows proper tracking as that case is assembled and disassembled. That’s how end-to-end traceability happens.

By tracking this “parent-child” relationship between pallet and case, and case and unit, it suddenly becomes possible to deal with challenging logistics, such as just-in-time inventory and targeted recalls.

The marketplace is inundated with providers who want to sell you vendor management software disguised as a traceability solution. Don’t be fooled. To deliver on current, emerging, and future demands, you must have granular, actionable data that you can access in real time. This kind of data is much more powerful than what most companies rely on today to protect their business.

Alas, despite the incredible — and demonstrable — value of serialization, many believe cost is a barrier to adoption. The truth, however, is that stringent pharma regulations in the United States, EU, and elsewhere are driving innovation, making serialization technology more affordable and reliable.

Furthermore, many forward-thinking food companies already have many of the pieces in place to take the next step. These include line systems, enterprise resource planning (ERP) software, and warehouse management systems (WMS), which make operations more accurate and efficient, and are the foundation upon which truly transformative change can be built.

Serialization is the essential step toward a modern supply chain. It can help ensure you are protected now and prepared for future challenges, from changes in regulation to an unexpected recall. Instead of playing catch-up tomorrow, the wise company will consider serialization today.

rfxcel and the HDA traceability seminar

The Healthcare Distribution Alliance (HDA) assembled various pharmaceutical supply chain industry leaders at its Traceability Seminar, last month in Washington, D.C.

The 2018 seminar focused on the upcoming Drug Supply Chain Security Act (DSCSA) implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.

The seminar educated the attendees with what to expect in the future as the industry approaches the final deadline and shared the available resources, tools and guidance on a range of traceability topics.

“For more than 15 years — from the advocacy stage through today — HDA has been a trusted partner for pharmaceutical traceability education,” said HDA Executive Vice President of Industry Relations, Membership and Education, Perry Fri. “Through our expertise, HDA is continuing to provide the pharmaceutical supply chain with opportunities, like the Traceability Seminar, to meet with a diverse group of professionals and DSCSA experts to share ideas, discuss important topics, seek out guidance and work toward common implementation goals.”

Real-time visibility in the supply chain is a strategic area of innovation at rfxcel. Within the seminar, rfxcel highlighted exactly how to overcome challenges and succeed when assessing, selecting, and installing an “extreme visibility” platform over the next few months.

“Our goal is to use this platform to have up-to-the-minute information on global events that could impact our supply chain, and provide this information to groups across the corporation.”

Key Deadlines

Adopting a phased approach, there are two key deadlines for different stakeholders: November 26th 2018 is the widely acknowledged deadline for pharmaceutical manufacturers and repackagers. On November 27th 2019, the DSCSA VRS deadline is enacted.  The wholesale industries must be compliant and only accept products that contain a serial number or product identifier, and they must verify this product identifier before they can go on to resell these goods. They must also be able to complete a validatable returns process.

To complete this process in specific regard to returned products that are saleable, the Verification Router Service (VRS) initiative was highlighted by the Healthcare Distribution Alliance (HDA) in its efforts to lead the industry in implementing the act.

Today, various solution providers, including rfxcel are in the process of providing a VRS.

 

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ABOUT RFXCEL

rfxcel is a supply chain track, and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.

 

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and more than 200,000 pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

HDA traceability seminar

Medicine Supply Chain: Don’t just tick the box, think outside of it

Serialization is much more than a rule to be obeyed – it’s a huge opportunity

Global pharma is teetering on the brink of a new world in which ground-breaking regulations impose strict serialization, traceability and verification obligations on the medicine supply chain. With deadlines for the adoption of DSCSA and FMD imminent it’s no surprise that companies are ramping up their efforts to assure regulatory compliance. Many businesses are adopting compliance-first (or indeed compliance-only) approaches that concentrate solely on ensuring they do the bare minimum to meet regulatory requirements. They’re ticking a box. The most proactive companies, however, have taken a different approach: they’re not ticking the box, they’re thinking outside of it – by focusing on quality and long-term value. It’s the right way to go. Here’s why.

Serialization is much more than a rule to be obeyed – it’s a huge opportunity for industry. But the possibilities will only emerge through a focus on quality right from the outset.

Key constituents of quality

Key to an effective serialization strategy is good technology, therefore the right partner and the best software is critical to success. However, the design, configuration and implementation of a system will ultimately be the difference between an approach that’s content with compliance and one that’s striving for added-value far beyond it.

The key phases of the adoption life-cycle typically include:

  1. Defining requirements

This requires robust insight into regulatory requirements, the holistic needs of the market and, later in the development curve, the specific business needs of individual organizations. Clearly defined requirements outline the scope of the opportunity and provide the baseline for your approach. Getting them right is imperative.

  1. Designing a solution

The development of core software requires continuous collaboration with a broad set of stakeholders to ensure the solution marries regulatory needs with recognizable industry processes and unique business characteristics. It also requires a full appreciation of the nuances of the medicine supply chain. It’s an iterative process.

  1. Characterizing processes

Process characterization is an essential component of a quality-first approach. Stakeholders must have a deep understanding of the solution, how it operates and the areas where it may break. Only by understanding how individual components interact with each-other is it possible to build an optimal system where everyone has confidence in the data.

  1. Validating processes

Hand-in-hand with characterization, achieving data quality requires robust validation of the processes established in the characterization phase. The best systems adopt ISPE’s GAMP 5 guidance for validation as a minimum.

  1. Monitoring

Quality-led systems build in automated, ‘always on’ monitoring so that organizations can detect and respond to problems or anomalies quickly and effectively.

Success is ultimately contingent upon having an effective change control system that allows companies to modify and maintain the quality of both the processes and the data within the system. Fundamentally, serialization depends on having accurate, secure and accessible data – as well as appropriate processes that can reliably and transparently accommodate change.

The long-term advantages of serialization extend far beyond satisfying regulations. Serialization naturally introduces traceability to the medicine supply chain, but could also be used to provide added value for pharma, providers and, crucially, patients. From a patient safety perspective, in addition to providing reassurance around the authenticity of medicines, it can help also accelerate and improve the granularity of product recalls – benefitting wholesalers, pharmacists and patients.

This powerful data can inform marketing strategy, improve patient support and stimulate patient-centred innovation.

A quality ambition

Ultimately, the success of your serialization efforts all comes down to ambition. The long-term, quality-first approach is underscored by a profound logic: compliance is a natural by-product of quality-driven objectives, but the reverse is seldom true. If the limit of your ambition is compliance, you may never achieve a quality solution. But if you’re unwavering focus is on quality… you’ll always be compliant. That’s why, when it comes to serialization, it makes sense not to just tick the box, but to think outside of it. Aim for quality – and you’ll be a serial winner.

ABOUT RFXCEL

rfxcel is a supply chain track, and trace company within the Life Sciences industry, helping companies meet regulatory compliance requirements, protect the product and ascertain brand reputation. Thought leadership and experience since 2003, expansions to locations in the US, EU, India, Brazil, and Japan, and a leading stand-alone traceability solution, the company, enables people, businesses, and industries to protect end consumers and their products. This unique integrated software delivers better business outcomes and lowers overall costs.

medicine supply chain

Are you Ready for EU FMD? Urgency, Consistency and Planning are Key

With the deadline looming for the enactment of EU FMD and US DSCSA, Vikash Pushpraj, SVP, rfxcel, explains how consistency in achieving compliance is about much more than technology. Companies not yet set up for serialisation will need to adopt best practices and leverage the know-how of implementation experts  in their methodology to go-live on time.

In February 2019, the Delegated Regulation to the Falsified Medicines Directive (FMD) comes legally into force in Europe, mandating Marketing Authorisation Holders (MAHs) to serialise individual medicine packs for authentication at the point of dispensation. But an even tighter deadline is just around the corner. This November, DSCSA requirements for package-level serialisation have finally come into play, midway through a 10-year roadmap for end-to-end traceability across the US supply chain. The question is: are you ready for it? And if you’re not, how can you get there before it’s too late?

The current landscape

Despite the proximity of the regulatory deadlines, suprisingly a number of companies have not yet established the infrastructure and processes required for serialisation.

The regulations have implications – and therefore active requirements – for the full gamut of stakeholders; manufacturers, brand owners, CMOs, third-party logistics providers (3PLs), wholesalers and dispensers. It’s therefore vital that pharmaceutical companies have a full understanding of the laws, requirements and the associated responsibilities of all parties in the partner network. Moreover, companies must map their entire supply chain operations to design systems that allow visibility, collaboration and agile workflow across a broad end-to-end process.

Serialisation Technology

Serialisation and traceability require aligning processes and software to generate, capture, share and affix data related to products’ unique identifiers (UIs). This data must also be accessible to downstream trading partners. If the data isn’t in the system – or it isn’t accurate or reliable – products will not get through the supply chain, with implications for both profitability and patient care.

The best solutions fixate on data quality and integrity, routinely monitoring information as it flows through the system to detect human error, inaccuracy and duplication. Robust validation is essential to prevent erroneous data from entering the differing international data hubs, including EMVO, DAVA and other national databases. Alongside it, connectivity is key. Solutions must ensure data flows securely, end-to-end, across the supply chain, connecting all parties to a single version of the truth.

Urgency, Consistency and Planning in Implementation

Solutions have to be not only custom-designed, but they must also be securely implemented at speed and scale. The best partners will, therefore, deploy implementation teams spread across the globe to ensure 24/7 availability with expertise in setting standard artefacts, automating processes and applying industry best practices to ensure a consistent and planned approach. These ‘hyper’ care teams will mobilise Subject Matter Experts in multiple time zones to maintain continuous engagement and activity throughout the implementation process.

The deadlines for DSCA and FMD and compliance are rapidly approaching and companies that have not yet prepared for serialisation need to move quickly and urgently, but with care and precision.

It’s time to factor time management into serialisation.