Category: publications

Complying with global pharmaceutical serialization and traceability regulations without collaboration and system interoperability represents a significant challenge for pharmaceutical trading partners.

Collaboration preempts disagreements among supply chain trading partners simply because complete, accurate data is important to both parties. Contract manufacturing organizations (CMOs) are a crucial component of the pharma manufacturing ecosystem, and many pharmaceutical companies depend on them.

Pharmaceuticals companies need to collaborate closely with their CMO partners on serialization to avoid compliance-related supply chain disruptions. At the same time, CMOs need to collaborate with the rest of their trading partners to prevent shipping and distribution issues.

Interoperability is crucial for installation, integration, and support for any company producing licensed products to achieve seamless compliance with the new serialization requirements.

The most challenging aspects of serialization projects are financial, technical, and operational. Collaboration from a financial perspective means understanding who will pay for the integrations. Talk to your partners about alternatives and choose a win-win option.

From a technical perspective, CMOs and customers must set up standards and agree on responsibilities for serial number standards, packaging, and label design. It’s also important to ask whether parties have the right resources, equipment, and IT infrastructure.

On the operational side, companies underestimate how time-consuming serialization is. It’s not only the initial integration but also maintaining the system as your companies grow. CMOs, CPOs, and other vendors should discuss this from the very beginning.

BENEFITS OF COLLABORATION

Aligning and collaborating within an established framework and processes ensures that the solution works seamlessly across organizational boundaries. Additionally, it is easier to validate systems and focus on data quality. And normalizing or correcting data has to be done before it is pushed further to other systems to avoid damage.

Collaboration among pharmaceutical manufacturers, CMOs, and trading partners will also boost serialization capabilities for better forecasts and decision-making. The detail in data that serialization brings can decrease the loss in product returns in situations when customers buy a product at a discount, and return it at full price. Companies can track the purchase price at unit level to avoid these situations.

The good news: Many solution providers offer integration-as-a-service as part of their software product; they have the ability and expert IT personnel to integrate systems and deliver ongoing technical support. Offering an integration service in addition to the solution keeps costs low by defining a framework, processes, and costs upfront.

Collaboration and system interoperability can help the pharmaceutical industry streamline the serialization process in the supply chain.

Jack Tarkoff, Chief Strategy Officer

Powered by IoT, EM solutions track cargo and provide actionable data that can mitigate common issues, change outcomes and protect brands and consumer health.

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 chain. EM 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.

According to PwC agribusiness advisory partner, 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 are 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 year, accounting for 34% of all cargo theft, according to a report by BSI Supply Chain Services and Solutions.

Food product quality and safety are also seriously compromised when cargo is poorly handled while in transit, with 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 money. Routing and EM have become more important in light of FSMA, which FDA 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?

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 pallets, cases 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 supply chain, 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 altogether. Recalls 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 stopped, where 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 crossing. With EM and tracking, businesses are able to understand and act upon specific risks using detailed, unit-level data.

For example, a company can find out if pallets have dislodged, fallen, or have been compromised in other ways while in transit. They can receive alerts if the doors of a truck are opened at an unscheduled time or location, which could indicate theft. Thieves 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 being 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 late. When 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 fraud. With 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.

Brazil’s 2015-16 zika epidemic saw around 4,000 babies born with microcephaly, as well as exposing serious flaws in the country’s public health service and basic sanitation problems.

Now, almost three years since the World Health Organisation (WHO) declared the outbreak a public health emergency, the ‘zika babies’ have become toddlers and many mothers continue their struggle to cope with the emotional and financial burdens of having a disabled child.

Catching the zika virus while pregnant often causes microcephaly, which involves a partial collapse of the skull, meaning the brain doesn’t develop properly. Later on in life, this brain damage can lead to the development of learning difficulties, muscle stiffness and, in some cases, partial blindness.

According to a report carried out Al Jazeera in December of last year, many Brazilian mothers in the northeast of the country say they still don’t receive financial support from the government, meaning the cost of medicines for their children is becoming too much to bear.

In fact, according to data from the Ministry of Health, since June this year, one third of children in Brazil with zika have not been able to access primary pediatric care.

When asked by Al Jazeera at the time of the report, the Brazilian government claimed they “hadn’t forgotten,” the babies born with the disease, pledging to spend another US $8 million this year on the rehabilitation centres they have already invested around $50 million in building, for children with rare disabilities.

With a new government around the corner, however, Human Rights Watch recently urged Brazil’s politicians not to forget the families who continue to suffer from the effects of the zika outbreak.

Given that recent outbreaks of the disease have been reported in both India and Angola, development of a vaccine against zika is becoming an increasingly pressing issue that the Pharmaceutical Journal argues is making “good progress.”

According to infectious diseases researcher Annelise Wilder-Smith, who was contacted in February of this year by the Pharmaceutical Journal, there are around 45 potential vaccines on the WHO tracker for zika, with most in preclinical development and some in phases I and II. However, because the number of cases are no longer considered to be part of an ongoing  public health emergency, momentum and funding for scientific research into the field is gradually decreasing.

Another issue vaccine-developing pharmacists are tackling is the global industry of falsified medicines, which are beginning to weave their way into developing countries such as Brazil.

One of the most recent scandals, reported The Guardian, involved the suspicious packaging of a vaccine discovered in Niger which caught the attention of a local pharmacist, who noted that the manufacturer was Brazilian pharmaceutical company Bio-Manguinhos/ Fiocruz. Upon contacting the Brazilian company, who confirmed they did not produce the vaccine, the decision was made to inform the WHO of the fake medicine, likely developed by a criminal group.

Speaking to Brazil Reports, Latin American director of pharmaceutical track and trace company rfxcel Vinicius Bagnarolli pointed out that between 10-20% of all pharmaceuticals are in fact counterfeits, meaning that around US $200 billion is spent annually on false medicines.

However, with false pharmaceuticals representing the largest global fraud market, Bagnarolli assured Brazil Reports that the country was leading the way for the development of regulations to monitor them, in the wake of a wave of US legislation which is due to come into effect in the near future.

“The government is doing a good job,” Bagnarolli said, praising the work Brazil’s public health system has carried out to combat the effects of the zika virus, not only in the development of medicines and vaccines, but also in providing basic sanitary education and establishing preventative methods.

Disclosure: This article includes a client of an Espacio portfolio company

Published by P3 Pharmacy

“The whole world is serialising,” says Martin Sawer, executive director of the Healthcare Distribution Association. He estimates that in some countries, up to 50 per cent of medicines are counterfeit.

“Manufacturers have been preparing madly over the past couple of years,” says ABPI director, Rick Greville, with the result that all packs of prescribable medicines will have a 2D scannable matrix from 9 February onwards. Products already on the market before then can be dispensed until their expiry.

However, anecdotal evidence suggests that uncertainty around how Brexit will be orchestrated means an alarming number of pharmacies still don’t believe FMD is going to happen, or at least don’t understand it. Nonetheless, the UK FMD Working Group for Community Pharmacy remains resolute in its advice to the sector. “The working group’s position has not changed and we urge people to engage with FMD, irrespective of any Brexit confusion and whatever our post-Brexit position might be,” says chair Raj Patel.

Practical steps

What are the practical steps to engaging with FMD, and where can contractors turn for advice?

Pharmacist Mona Koshkouei is pursuing a doctorate in paediatric medicine at the University of Oxford. Her research focus is on the operational and clinical impact of regulatory change of FMD on healthcare systems within Europe and specifically primary and secondary care within the UK. She believes that for community pharmacies in particular the key steps are “understanding what this change will mean for them, taking into consideration their processes, customer/patient base, IT infrastructure and financial investment or impact”.

That sounds like a lot to consider, but Ms Koshkouei says there are a number of sources of information available. “The MHRA has a dedicated email address for FMD implementation queries (FMD.safetyfeatures@mhra.gov.uk), the UKFMD Working Group for Community Pharmacy has information on its website (www.fmdsource.co.uk) and NHS Digital is in the process of creating guidance toolkits for healthcare providers across a number of sectors.”

“With more than 130,000 community pharmacists, hospitals and doctors being impacted by the deadline, pharmacists should look to their associations for advice in meeting compliance ahead of the deadline,” says Graham Smith, general manager of healthcare and pharmacy, EMEA, at TraceLink, a SaaS (software as a service) platform for tracking and tracing pharmaceuticals. “However, because much of the information in the market is outdated or inaccurate, it is important to understand the options for cost-friendly, flexible solutions that naturally fit into existing workflows or can be added on with slight modifications.”

The bottom line is that pharmacies will need an FMD scanning system that connects into the UK’s national verification system, managed by not-for-profit third party supplier SecurMed UK. There are two options for this, both of which you have to pay for yourself. Speaking at a panel discussion on FMD at this year’s Pharmacy Show, Leon Finnerty, programme lead at NHS Digital, explained that the options were to either “go with your existing pharmacy system supplier” or choose from “a number of standalone systems”.

Getting on board

Whatever you choose, each community pharmacy in the UK will have to go through an ‘onboarding’ registration process, which identifies them as a legitimate pharmacy and grants them an account to connect to the UK FMD system.

At the time of writing, SecurMed has not yet opened up the process. “The onboarding process described at securmed.org.uk specifies the information that will be required and the process that SecurMed will take for verifying the information,” says Oliver Staunton, pharmacist, co-founder and developer at PharmData. “The end user registration process is still not available, though I believe it may be in early November.

“After onboarding, there will be a registration process between the pharmacy and whichever software provider they have chosen, so depending on the provider, there may be a site visit for installation and training, or online installation, or the pharmacy may simply set up the software themselves.”

More to do

In order to avoid disruption during the Christmas and New Year period and to allow time for staff training, the UK FMD Working Group has urged pharmacy contractors to plan to complete registration as soon as possible, but how well prepared are pharmacies?

Speaking on behalf of the FMD Working Group for Community Pharmacy, Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance, says: “Most people have been well aware of FMD for a long time and it will work if everybody does their bit. The IT is in place – with about 80 companies registered now to do development, so the chances are your PMR supplier has got it in hand and most system suppliers are out of ‘the sandbox’ testing phase – plus manufacturers, wholesalers and pharmacies are beginning to gear up, although some are more advanced than others.”

Ms Koshkouei says preliminary studies have indicated that community pharmacies are at varying stages of ensuring compliance with FMD. “With ongoing clarifications being sought by pharmacy providers and a live test with the UK Medicines Verification System pending, it would not be an unreasonable assumption that 100 per cent compliance may not be achieved across all pharmacy sectors in time for launch,” she says.

Brexit and FMD

If this isn’t enough to be getting on with, it seems as if the MHRA is suggesting that FMD could be revoked just weeks after implementation, in the event of a no-deal Brexit.

At the Pharmacy Show, Claymore Richardson, a senior policy manager at the Department of Health and Social Care (DHSC), referred to a recent MHRA statement clarifying that in the “unlikely” event of no deal and with no agreement on the post-Brexit transition period, FMD would, by law, have to be revoked “because you can’t have something that’s legally impossible to comply with”.

This is because continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. “From a legal point of view, if we crash out of Europe with no withdrawal agreement and no transition period, we have no right to plug into the European FMD hub and they have the right to pull the plug on anyone not in the club,” says Mr Buisson.

Malcolm Harrison, chief executive of the CCA, has said: “In the event of the UK Medicines Verification System being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.”

Drop-dead dates

With the FMD deadline only a few months away, Mr Buisson says the time for action is now. “Serialisation is a global approach, so actually, the ‘drop-dead dates’ dropped dead months, if not years, ago,” he says. “Having said that, I expect a lot of tweaks to go on after 9 February, with software updates that build on real world experience.”

There’s going to be a long transition and Ms Koshkouei advises that, while pharmacies must be FMD compliant by 9 February 2019, “there is also a wash-out period where not all medicinal items will bear the safety features and so there will exist a natural phasing in of the verification and decommissioning workload”.

Non-compliance

For those who don’t – or won’t – get on board, it’ll come as no surprise that a recent DHSC and MHRA consultation contains a section on sanctions for non-compliance.

“One approach would be the sole use of criminal sanctions for failure to comply with the requirements of the Delegated Regulation, with a person liable on summary conviction to an unlimited fine or liable on conviction on indictment to a fine, or to imprisonment for a term not exceeding two years, or to both,” says Zeeshan Ahmed, global serialisation expert, director and co-founder at Sigma Advance Consulting. “However, government is minded to move to an approach that would use a mixture of criminal and civil sanctions. Such civil sanctions might include written warnings, stop notices and civil fines, before the application of criminal sanctions, which would only be used for the most serious, intentionally fraudulent, breaches.”

Mr Richardson confirmed that the MHRA is the overall enforcement agency for the Directive, but it will work with the relevant regulatory bodies (GPhC, CQC and others) to put FMD into the inspections it already has.

Mark Davison, senior operations director, Europe, at rfxcel Corporation, which provides SaaS-based track and trace solutions for the pharmaceutical supply chain, suggests that “in theory, MHRA could start inspection and sanctions on 9 February when the FMD goes live”.

“Why would you not comply?” says Mr Buisson. “Why, in effect, would you say you are happy to supply falsified medicines? FMD is happening, so your best bet is to get informed, get on board and keep your eyes open for further information that’s coming, as well as guidance on what you do if things go wrong, which we’re working on right now.”

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.

Published by European Pharmaceutical Manufacturer (EPM)

On 9 February 2019,  more than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines. We’ve had two-and-a-half years of the three-year implementation window now: what conclusions can we draw and what recommendations can be made?

1. It will happen.

Those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020. Will everything be ready by February? No, quite clearly not, especially at pharmacy level. That doesn’t mean the whole project will stop.

2. It’s too late.

If you’re a marketing authorisation holder (MAH) and still need to convert production lines then it is too late to be ready. You have two options. You can make excess inventory, release it before February, and hope it lasts until your lines are ready, or you can send your finished goods to a contract manufacturer (CMO) for coding. Both inconvenient, but you’re still in business.

3. It isn’t too late.

There is still time to get ready if you just need software to manage and report serial numbers (e.g., to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, ACT NOW, and you could have your software implemented within the next few months.

4. Choose experience over price.

Saving a few thousand euros using unproven but cheap serialisation vendors is a false economy if you can’t sell or dispense products by next February. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

5. KISS

Simple FMD projects work best. Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). There is the ability to integrate with your FMD solution, with the planning software, warehouse system, dispensing software or your Apple Watch if you want to. It’s not just for those items on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

6. Adapt processes, train people.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

To learn more about Supply Chain Visibility click here

To learn more about Regulatory Compliance Software click here

Published by Contract Pharma

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—and similar legislation in other important regions just around the corner—it’s no surprise that companies are ramping up their efforts to assure regulatory compliance.

Pharma is in the jaws of change and no-one wants to get bitten. But perhaps, at times, companies’ emphasis is imbalanced. In some organizations, an understandable but blinkered focus on achieving compliance may be driving operations at the expense of a far more important attribute: quality. 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 seizing it requires a visionary approach. Pharmaceutical companies should look beyond the functional requirements of compliance and instead design ‘quality-first’ strategies that explore how serialization data can be leveraged to deliver long-term value. The potential is significant. With innovation and creative forward-thinking, future applications of serialization data could help transform old models of care. But the possibilities, which we’ll examine later, will only emerge through a focus on quality right from the outset when developing a serialization strategy and procuring the tools to deliver it.

So what does a quality-first approach look like? Here are the main considerations.

Key constituents of quality
The key to an effective serialization strategy is good technology. It’s why identifying the right partner and the best software is critical to success. However, there’s more to serialization than simply acquiring the basic functionality of track and trace. 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.

A good technology partner will therefore seek to build quality into their product, their service and their culture. That focus on quality will show itself at all the key phases of the adoption life-cycle.

These typically include:

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

2. Designing a solution
The development of core software, which will later be configured to meet individual business requirements, 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.

3. Characterizing processes
Process characterization is an essential component of a quality-first approach. It’s vital that all stakeholders have a deep understanding of the solution, how it operates and the areas where it may break. It’s only by understanding how all the individual components interact with each other that it’s possible to build an optimal system where everyone has confidence in the data that comes out of it.

4. Validating processes
This phase goes hand-in-hand with characterization. With data integrity the hallmark of a quality system, achieving it 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.

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

Change control
These crucial aspects form a virtuous circle of quality that enables companies—through continuous monitoring and engagement—to take an agile, iterative and collaborative approach to system design and implementation. However, 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.

GMP guidelines stipulate that users of computer systems must always be in control, yet some multi-tenant serialization solutions impose software updates on users without warning, leaving them out of control. The impact on quality is substantial. Fundamentally, serialization depends on having accurate, secure and accessible data—as well as appropriate processes that can reliably and transparently accommodate change across a global organization. Insufficient change control can adversely impact performance in these key areas and significantly impair quality.

Why bother?
The value of working with a trusted partner that takes a quality-first approach to serialization cannot be overstated. The compliance benefits are obvious, but they’re the minimum requirement. The long-term advantages, which are dependent on designing a system that maximizes all the data flowing through it, extend far beyond satisfying regulations.
Serialization naturally introduces traceability to the medicine supply chain. However, this data 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.

There’s also great potential to use serialization data to monitor and support patient compliance. Medicines adherence is a major, and costly, global challenge. Serialization could help companies identify poor adherence, as well as understand who is buying a product and where and how they’re using it. This powerful data can inform marketing strategy, improve patient support and stimulate patient-centered innovation.

The possibilities are boundless. Some of the best ideas are yet to be conceived. However, to be in with a chance of developing and exploiting them, pharmaceutical companies must seize the moment and take a long-term view on serialization. The potential benefits reinforce the importance of working with a trusted partner that takes a quality-first approach. An expert partner will work with you from the outset to help shape strategy and design solutions that provide value beyond compliance.

A quality ambition
Ultimately, the success of your serialization efforts all comes down to ambition. Are you simply looking for compliance or striving for something more? The answer is common sense. 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 your 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.

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.

To learn more about our Quality and Validation efforts click here.

Vinicius Bagnarolli, Director of Operations in Latin America for rfxcel, says the time to start preparing is now.

Sweeping changes are coming to Brazil’s pharmaceutical supply chain. Since 2009, the Brazilian Health Regulatory Agency (ANVISA) has been honing the National Medicine Control System (SNCM), a traceability system designed to establish mechanisms and procedures for tracking and tracing drugs. After several amendments and resolutions and a one-year pilot phase, SNCM will go into full effect in May 2022.

rfxcel, the leader in track and trace solutions for the pharmaceutical industry, has prioritized helping Brazilian companies prepare for SNCM. Though the system will not “go live” for 34 months, Vinicius Bagnarolli, rfxcel’s Director of Operations in Latin America, says pharmaceutical companies should start preparing now.

“Three years may seem like a long time, but it’s not,” he says. “SNCM requires pharma companies to do a lot of new things and adopt new behaviors. This includes implementing unit-level serialization, tracking and tracing products, and monitoring environmental conditions as they move through the supply chain. Companies will also have to submit detailed transaction data to the government. We want companies, distributors, and dispensers to know that we have the technical expertise and experience in Brazil to help them transition to SNCM. We are on the ground in Brazil; we are here to help.”

SNCM is essentially a modernization scheme: Every supply chain actor must be able to capture, store, and exchange data electronically. All products must have a GS1 DataMatrix bar code that houses a Global Trade Item Number (GTIN), an ANVISA Medicine Registry Number, a unique serial number, an expiration date, and a lot/batch number. Such internationally accepted measures will enable Brazil to protect its almost 190 million citizens against common problems in the drug supply chain, including counterfeit drugs and cargo theft.

“This is a great step for my country,” he says. “Europe and the United States have implemented similar laws successfully. Brazil is the biggest economy in Latin America and is among the biggest in the world; SNCM should be celebrated as a statement of intent that Brazil’s drug industry will follow global quality trends.’’

Bagnarolli also stresses that companies in Brazil must realize SNCM is here to stay, that ANVISA is not going to “babysit” the pharma industry, and that stakeholders must be proactive now to avoid complications with infrastructure and compliance later. “The industry’s business is to sell medicine. rfxcel’s business is supply chain technology. We want companies to focus on what they do best and let us do the rest.”

rfxcel Vice President of International Business Mark Davison agrees. “Organizations in the medicine supply chain urgently need clarity and support from experienced traceability solution providers,” he says. “SNCM is challenging, but rfxcel has built its requirements into existing business workflows, creating opportunities to improve patient safety and supply chain efficiency.”

rfxcel’s main advantage is experience. In business for 15 years, it has deployed its cutting-edge track and trace software to hundreds of companies in the world’s largest markets, including the United States, the EU, India, Russia, and Saudi Arabia. It manages billions of serial numbers, empowering companies with fine-tuned, unit-level, actionable data that optimizes performance and safety while mitigating logistical, environmental, and compliance problems.

Trust, accountability, and transparency are other value-adds rfxcel brings to the table. Every step a customer takes with rfxcel is visible to its team and a dedicated rfxcel team. From onboarding and training to implementation and real-time support, rfxcel works hand-in-hand with its customers to ensure their supply chains are safe, efficient, optimized, and fully compliant.

Bagnarolli wants pharma stakeholders in Brazil to ask themselves several important questions:

1. How will you develop your ANVISA onboarding framework?
2. What should you do between now and 2022, before the definitive implementation plan rolls out?
3. What is the best way to incorporate GS1 DataMatrix codes and serial numbers?
4. What are your options for partnering and collaborating with your trading partners to ensure you meet all requirements by 2022?
5. How can you guarantee compliance to avoid fines, supply chain delays, product confiscations, and financial losses?

“These are complex questions,” he says. “But rfxcel is ready to provide guidance and analytics on how to best approach the new regulations. Our unique software capabilities have helped companies around the world meet stringent compliance requirements, safeguard their supply chains, and expand their markets.”

Bagnarolli concludes by saying that rfxcel’s main concern is to make Brazil’s pharmaceutical industry safer. Noting that the country’s pharma market is valued at roughly $31 billion — the sixth largest in the world — he says, “We are here to build relationships based on trust so companies can be compliant by 2022. We want to talk about and advise on the hard work it will take to meet technical requirements, build new teams, and communicate and integrate with trading partners.”

Bagnarolli invites companies to contact him for a consultation. He envisions hosting a webinar or similar training sessions, and welcomes opportunities to visit companies to help them be ready for SNCM.

For more information contact us at latam@rfxcel.com

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet

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 platform delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

Published by R&D Magazine

Pharma is in the jaws of change and no-one wants to get bitten. But perhaps, at times, companies’ emphasis is imbalanced. In some organizations, an understandable but blinkered focus on achieving compliance may be driving operations at the expense of a far more important attribute: quality.

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 seizing it requires a visionary approach. Pharmaceutical companies should look beyond the functional requirements of compliance and instead design “quality-first” strategies that explore how serialization data can be leveraged to deliver long-term value. The potential is significant.

With innovation and creative forward-thinking, future applications of serialization data could help transform old models of care. But the possibilities, which we’ll examine later, only will emerge through a focus on quality right from the outset when developing a serialization strategy and procuring the tools to deliver it.

So what does a quality-first approach look like? Here are the main considerations…

Key Constituents of Quality

The key to an effective serialization strategy is good technology. It’s why identifying the right partner and the best software is critical to success. However, there’s more to serialization than simply acquiring the basic functionality of track and trace. 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.

A good technology partner will therefore seek to build quality into their product, their service, and their culture. That focus on quality will show itself at all the key phases of the adoption life-cycle. These 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. It requires deep, broad, and sustained engagement. Clearly defined requirements outline the scope of the opportunity and provide the baseline for your approach. Getting them right is imperative.

2. Designing a solution

The development of core software—which will later be configured to meet individual business requirements—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.

3. Characterizing processes

Process characterization is an essential component of a quality-first approach. It’s vital that all stakeholders have a deep understanding of the solution, how it operates and the areas where it may break. It’s only by understanding how all the individual components interact with each other that it’s possible to build an optimal system where everyone has confidence in the data that comes out of it.

4. Validating processes

This phase goes hand-in-hand with characterization. With data integrity the hallmark of a quality system, achieving it 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.

5. Monitoring

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

Change Control

These crucial aspects form a virtuous circle of quality that enables companies—through continuous monitoring and engagement—to take an agile, iterative, and collaborative approach to system design and implementation. However, 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.

GMP guidelines stipulate that users of computer systems must always be in control—yet some multi-tenant serialization solutions impose software updates on users without warning, leaving them out of control. The impact on quality is substantial. Fundamentally, serialization depends on having accurate, secure, and accessible data—as well as appropriate processes that can reliably and transparently accommodate change across a global organization. Insufficient change control can adversely impact performance in these key areas and significantly impair quality.

Why Bother?

The value of working with a trusted partner that takes a quality-first approach to serialization cannot be overstated. The compliance benefits are obvious—but they’re the minimum requirement. The long-term advantages, which are dependent on designing a system that maximizes all the data flowing through it, extend far beyond satisfying regulations. Serialization naturally introduces traceability to the medicine supply chain. However, this data 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—benefiting wholesalers, pharmacists and patients. There’s also great potential to use serialization data to monitor and support patient compliance.

Medicines adherence is a major—and costly—global challenge. Serialization could help companies identify poor adherence, as well as understand who is buying a product and where and how they’re using it. This powerful data can inform marketing strategy, improve patient support, and stimulate patient-centered innovation.

The possibilities are boundless. Some of the best ideas are yet to be conceived. However, to be in with a chance of developing and exploiting them, pharmaceutical companies must seize the moment and take a long-term view on serialization. The potential benefits reinforce the importance of working with a trusted partner that takes a quality-first approach. An expert partner will work with you from the outset to help shape strategy and design solutions that provide value beyond compliance.

A Quality Ambition

Ultimately, the success of your serialization efforts all comes down to ambition. Are you simply looking for compliance or striving for something more? The answer is common sense.

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 your 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.

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.

Published by European Pharmaceutical Manufacturer (EPM)

The pharmaceutical industry’s understanding of serialisation is maturing as companies slowly begin to recognise the added business value supply chain traceability can provide. Historically, the industry’s focus on serialisation has been driven by the need to satisfy evolving regulations. However, progressive companies are finally realising that the benefits of traceability extend far beyond compliance.

Serialisation unlocks an end-to-end supply chain visibility that has the potential to yield significant business gains. Through the smart deployment of fully integrated and validated solutions, forward-thinking organisations are looking at the bigger picture, and using serialisation as a catalyst for operational efficiency, enhanced partner engagement, and stronger patient-centred care. It’s a sensible move.

With the clock ticking towards the enactment of major new regulations to strengthen the medicines supply chain, the industry has a great opportunity to convert compliance into competitive advantage; but exploiting it is all about selecting a technology partner that can give you the visibility to support your vision.

Regulatory drivers

The regulatory drivers for serialisation are well-understood. Between 10–15% of the world’s drug supply is counterfeit, causing the avoidable deaths of more than 100,000 patients each year. Patients — and governments — need reassurance that medicines are authentic and safe. Imminent regulations — such as the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA) — are designed to combat counterfeit medicines, mandating complete visibility of a drug’s journey from manufacturer to patient. Serialisation, a core requirement of both FMD and DSCSA, will not only enhance patient safety, it will help eradicate the hundreds of billions of revenues pharma loses every year due to counterfeit practices.

Serialization is about much more than being compliant. It adds four orders of magnitude to supply chain visibility, giving pharma companies the opportunity to increase the value they provide to stakeholders involved in a drug’s journey from bench to bedside. That journey typically encompasses manufacturers, contract manufacturers (CMOs), logistics providers, wholesalers, distributors, dispensers and, ultimately, patients. Serialisation has the potential to add value every step of the way — providing transparent, reliable and accessible data to drive efficiencies, manage and maintain stock control and assure product provenance.

The imminent addition of individual serial numbers to every prescription medicine represents a seismic shift for supply chain management. Today, companies have batch-level visibility of their medicines — meaning that, every day, several thousands of their products are indistinguishable as soon as they leave the warehouse. Tomorrow, with serialisation, every product will be identifiable as a distinct entity; companies will know what it is, and (system rules permitting) where it is, where it’s been and where it ends up. Such end-to-end visibility could, beyond satisfying regulations, have powerful, high-value applications.

The introduction of serialisation presents significant challenges around business integration and risk. Companies need to ensure that the data associated with every unique entity stays with that product, with full integrity, as it moves through the supply chain. It’s a complex process that, without robust validation and integration, is prone to risk. But getting it right has the potential to transform the value pharma provides to every stakeholder.

#1: Value to the patient

If we reverse engineer the supply chain journey and begin with the end-user, it’s easy to visualise a future where patients can reap the value of serialisation. At present, the emergent regulations don’t require manufacturers to give patients access to information on product authenticity. Patients have to trust that the dispenser issuing the product has verified its legitimacy. The approach will not last forever. Over time, consumers will expect to be able to scan a barcode on a drug to access further information on its provenance and use. We’re not there yet, but in a world of patient empowerment, it’s an inevitable destination. The technology is already there to support it.

Ultimately, the vision of every pharma company is to be patient-centred. Serialisation provides a new means of achieving it.

#2: Value to the dispenser

FMD and DSCSA certainly strengthen product visibility at the dispenser level. But there remain gaps in the regulation that good technology can overcome. In the US, dispensers are only required to validate ‘inbound’ products as deliveries are received. In the EU, serial numbers are validated at the point of sale. However, in each case, the law doesn’t require dispensers to track and trace products within their own enterprise. This can mean that dispensers lose visibility of products once they’ve been received and validated. Although visibility in the EU reappears when the product is dispensed, the information vacuum in between is a missed opportunity.

Full track and trace capabilities can empower dispensers to manage stock control and inventory more efficiently. This reinforces patient safety and helps businesses maintain profitability with better, real-time analytics. Crucially, it provides added value beyond regulatory requirements.

#3: Value to the wholesaler

Good serialisation software can help manufacturers solve a major challenge facing one of their most powerful customers: wholesalers. There’s currently widespread concern amongst wholesalers that serialisation could slow down their operations. The regulations only require manufacturers to let wholesalers know which serial numbers they have received. In some cases, manufacturers are refusing to give wholesalers aggregated ‘case IDs’ that detail all the serial numbers in a given case. Consequently, wholesalers — who didn’t previously need to open cases — are now having to do so. This impacts the velocity of the wholesaler’s business. Smart serialisation software makes this easier — allowing manufacturers to manage aggregation and wholesalers to capture aggregated case data, and maintain compliance, via a single barcode scan.

Similarly, full track and trace capabilities can help wholesalers manage operations more efficiently. Wholesalers typically need to break up pallets so that cases can be sent to a variety of locations and retailers. Maintaining visibility of individual units is critical. Effective solutions can help wholesalers maintain accurate connections between purchase orders and customers. Moreover, robust visibility can help other complex challenges such as reverse logistics and audit requirements.

#4: Value to the manufacturer; brand owners and CMOs

Finally, end-to-end traceability provides terrific value to manufacturers. With pharma companies increasingly outsourcing to CMOs, brand owners often have limited visibility of remote activities. Serialisation solves that challenge. With a good end-to-end solution, and collaborative business partners, manufacturers can benefit from real-time analytics of performance across their partner network. How many units have been manufactured? How many shipped? Were there any issues? Moreover, companies can access intelligence on reverse logistics — enjoying full visibility of returns from wholesalers or dispenser and the reasons for them. Such visibility can also help with complex pricing or ‘diversion’ challenges.

Catalyst for competitive advantage

Regulatory compliance is undeniably the primary driver for the deployment of serialisation solutions. However, with organisations already spending heavily to refit their manufacturing lines for serialisation, serialisation software must provide significant value beyond compliance. The best systems will be those that focus on data validation and integration to create a ‘single version of the truth’ for stakeholders across the supply chain. Moreover, they’ll provide full end-to-end visibility to help drug companies — and all their partners — improve operational efficiency, increase profitability and give patients safe, timely access to authentic medicines. That’s how you convert compliance into competitive advantage.

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.

Published by European Pharmaceutical Manufacturer (EPM)

The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. By February 2019, MAHs will need to start uploading serialisation codes for almost all their prescription medicines to the European Medicines Verification Organisation (EMVO) hub for authentication with pharmacists at the point of sale. Those that can’t will simply be unable to sell their products in Europe.

The FMD is fast approaching, with the denouement arriving 9 February 2019, when the directive is fully enforced and the penalties for non-compliance officially come into play. FMD is an attempt to prevent inauthentic, substandard or harmful medicines entering the supply chain. It imposes strict serialisation, traceability and verification requirements on pharmaceutical manufacturers and their associated wholesalers, distributors and contract manufacturers. In particular, it mandates companies to print a unique identifier (UI) on the packaging of prescription medicines. Furthermore, companies aren’t just responsible for the data that goes on the packaging, they’re responsible for submitting it to the central data hub — EMVO — that will enable pharmacists to authenticate products before they dispense them.

The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health. However, failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No code, no trade. And those in the driving seat are MAHs, who are ultimately accountable for compliance and for uploading UIs to EMVO, which in turn distributes these to the appropriate National Medicine Verification System (NVMO) in the market where the product will be dispensed.

Despite the significance of the regulation, there are some pharmaceutical manufacturers who have yet to put a strategy in place to assure compliance. For these MAHs, it is rapidly becoming imperative to think about strategic decision-making. I developed the following DRASTICprocess.

Decision making

The significance of serialisation is often underestimated. Responsible managers at smaller MAHs will typically have multiple job functions, only one of which is serialisation. Not only that, but it’s typically considered a production issue and operational challenge. Yet serialisation is a board level issue, with ramifications that could directly affect business performance. Indeed, it’s not a manufacturing cost — it’s a business continuity risk that touches every aspect of an organisation.

So, the first step towards serialisation — one that’s often overlooked — is for the MAH to identify and appoint an executive sponsor, ideally with board level oversight, to lead a holistic strategy. Implementation will naturally be delegated to project teams, but executive leadership will be crucial to making things happen quickly.

Reality check

Many organisations don’t understand all their business processes in sufficient detail to overlay serialisation. It’s therefore vital that a multi-disciplinary team (MDT) is convened at the earliest opportunity to map the process flow of the business and establish a roadmap of how serialisation can be applied across multiple organisational boundaries. The MAH should actively engage MDT representatives from manufacturing, supply chain, IT, legal/regulatory and partner/contract management.

Analysis

The barcodes required for FMD must include four lines of data; Global Trade Item Number (GTIN), serial number, batch number and expiry date. Some countries require a fifth element, usually for national reimbursement purposes.

These datasets often live in disparate systems within organisations. The master data — including GTINs — is fixed information that’s commonly stored in an enterprise resource planning (ERP) system. Although that data doesn’t change, it still requires attention to ensure it’s clean and accurate when uploaded to the repositories.

In terms of variable data, the processes required to generate serial numbers, transfer them to production and ensure they’re used appropriately are complex. Analysing where the data sits and how it flows throughout the supply chain lifecycle is key to successfully managing this immensity of numbers; mistakes can lead to expensive delays, medicines shortages and loss of revenue. Serialisation software is therefore an essential requirement to help you maintain control of all aspects of fixed and variable data.

Strategy

The next step is to define your user requirements and establish a template for the solution that will help ensure you’re compliant. You must consider immediate and long-term factors. For example, which markets do you currently ship product to and which do you plan to target in the future? Which products in both your portfolio and your pipeline will need to be coded? Is there a potential future requirement to be able to track and trace products as they journey through the supply chain?

Regulations, from FMD to the US Drug Supply Chain Security Act (DSCSA), serialisation mandates differ from country to country and are constantly evolving. Take the opportunity to become ‘future ready’ by creating a design template that doesn’t just focus on FMD but is flexible enough to be interoperable and implementable between national systems and provides the flexibility to adapt to change as it happens.

To learn more about Supply Chain Visibility click here.

To learn more about Regulatory Compliance Software click here.