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The Ultimate Guide to Supply Chain Visibility: Enhancing Efficiency and Performance

Posted on by rfxadmin

The ability to monitor each part of your supply chain helps your business mitigate risk, serve customers better, and work more efficiently. Find out more about the importance of supply chain visibility in this guide from Antares Vision Group and rfxcel.

Understanding Supply Chain Visibility

Modern business operations require a high level of coordination and logistics. A company may source raw materials from one location, have a manufacturing facility in another location, and deliver products to customers all over the world. To produce, package, and ship goods efficiently, they need a centralized tracking system.

Supply chain visibility traces a product from its raw materials and through the manufacturing process to the point at which it reaches a customer’s doorstep. A visibility solution allows a business to track all its goods through every step in the supply chain. Supply chain visibility can:

  • Increase efficiency
  • Ensure customer satisfaction
  • Inform decision-making
  • Improve sustainability

Ultimately, visibility – or lack thereof – affects your bottom line.

Benefits of Supply Chain Visibility

To stay competitive in today’s globalized economy, businesses need efficient systems for monitoring supply and demand. Supply chain visibility benefits include:

  • Tracking: Real-time tracking and traceability tools streamline inventory management, offering automation for many routine tasks.
  • Efficiency: Visibility tools enhance the accuracy of demand forecasting and reduce the likelihood of stockouts.
  • Risk management: Full visibility means that teams can respond more quickly when there is a supply chain disruption, mitigating the risk and minimizing delays.
  • Optimization and better collaboration: Supply chain management systems help companies communicate better with suppliers, optimizing relationships and fostering collaboration.

Key Components of Supply Chain Visibility

Although supply chain visibility systems may differ from company to company, they all focus on transparency at each node of the supply chain. This includes:

  • Inventory visibility: Companies can track and manage inventory levels and procurement across all their locations.
  • Transportation visibility: All products in transit can be tracked and monitored in real time.
  • Demand visibility: Robust supply chain network data allows businesses to understand customer patterns and forecast demand more accurately.
  • Supplier visibility: Real-time visibility tools allow you to monitor supplier performance and ensure timely deliveries.
  • Data visibility: By collecting information about inventory, transportation times, and more, companies can turn data analytics into actionable insights and adjust workflows or supply chain processes.

Implementing Supply Chain Visibility

Putting supply chain visibility tools into place takes time and effort, but it’s well worth the benefits you’ll reap in operational efficiency and better business performance. To implement supply chain visibility, start by assessing your current systems. Look for areas of improvement across the supply chain – have you experienced stockouts in a particular product line? Do you struggle to meet customer demand at a certain time of year?

Next, look for the right technology solutions that can enhance visibility across your entire ecosystem. Perhaps you have a good system in place for monitoring customer orders but need a better way to manage suppliers. Look for supply chain software that can integrate with your existing systems and address gaps in visibility.

You need a seamless flow of information across your technology platforms. Additionally, prioritize data security in any supply chain visibility initiative. Compliance with data privacy regulations is a must for your company, as well as any suppliers, shippers, or distributors you work with.

Best Practices for Supply Chain Visibility

Whether you work in pharmaceuticals or food and beverage, certain practices will improve visibility across the entire supply chain. These include:

  • Metrics: Have a clear set of goals and metrics in place that you will use to measure your success.
  • Collaboration: Build strong partnerships with suppliers to enhance transparency and efficiency.
  • Technology: Invest in cloud-based platforms and advanced analytics tools with built-in supply chain security.

Above all, adopt a proactive approach to risk management and contingency planning. While some supply chain disruptions are out of your control, having a plan in place will make it easier to minimize inefficiencies and shortages.

Overcoming Challenges in Supply Chain Visibility

Even with the best-laid plans, you may face roadblocks when trying to improve end-to-end supply chain visibility. Potential challenges include:

  • Supply chain data quality issues and data silos
  • Resistance to change and organizational barriers
  • Regulatory compliance and data privacy concerns

Managing a significant volume of data, especially when you are working in the context of a complex global supply chain with multiple partners and stakeholders, can feel overwhelming. That’s why it’s so important to find supply chain visibility software that integrates with all your data collection systems. You should look for a software service provider that is well-versed in regulatory compliance and has built-in data protections.

Understand that even when you choose an intuitive, user-friendly system, you’re likely to face pushback from some employees or partners. Plan a thoughtful implementation and roll-out process, with time built in for staff training. This will help address any concerns.

The Future of Supply Chain Visibility

Emerging technologies and digital transformation are changing the supply chain management landscape. Already, we’re seeing the value of artificial intelligence (AI) and machine learning in supply chain software solutions. AI-powered tools can analyze real-time data to inform forecasting, using predictive analytics to inform orders, pricing, warehouse placement, and more.

The Internet of Things (IoT) and blockchain technology are also shaping supply chain visibility. By giving all supply chain stakeholders access to the same information, blockchain tools can potentially reduce fraud and data errors while improving communication. And the proliferation of IoT devices means that real-time tracking is easier throughout order processing and delivery.

We’ll Help You Achieve Supply Chain Visibility

We offer supply chain visibility solutions that prioritize efficiency and compliance management. With offices in the United States and abroad, we serve clients in sectors including:

  • Pharmaceuticals
  • Food
  • Beverage
  • Consumer goods
  • Government

For information on our supply chain visibility tools or to request pricing, contact us today.

Food Safety Modernization Act (FSMA): Guidelines, Regulations, and Impact

Posted on by rfxadmin

Passed in 2011, the Food Safety Modernization Act (FSMA) authorized major changes to how the U.S. food supply chain operates. Growers, processors, and food manufacturers are all subject to new regulations intended to prevent foodborne illness and make the food supply safer, traceable, and more transparent. Learn more about FSMA, what it covers, and how it affects food safety compliance in this guide from rfxcel.

Food Regulations and Enforcement in the USA

Before the introduction of the Food Safety and Modernization Act, the Food and Drug Administration (FDA) provided industry guidance on how to reduce food safety hazards. While food businesses could become certified in Good Agricultural Practices (GAP) and Good Handling Practices (GHP), the guidelines offered by FDA were not enforceable. 

FSMA expands FDA’s oversight, offering a clear regulatory framework and a set of preventive controls designed to take a proactive approach to food safety.

Importance of Food Safety

A safe and reliable U.S. food supply is critical, both for public health and national food security. According to the Centers for Disease Control and Prevention, foodborne illness affects one in six Americans each year and accounts for 3,000 deaths annually. Investing in food safety measures is important for many reasons. Robust federal support for food safety:

  • Improves consumer confidence in America’s food supply
  • Reduces the burden on the U.S. healthcare system by keeping people healthier
  • Helps detect and contain foodborne illness outbreaks before they spread

What Is the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA), signed into law in January 2011, authorizes the U.S. Food and Drug Administration (FDA) to take a preventive approach to food safety problems. This new approach gives FDA the authority to establish food safety standards for stakeholders throughout the food and beverage industry supply chain. FSMA amends the Federal Food, Drug, and Cosmetic Act, first passed in 1938.

Why Did the Food and Drug Administration Pass FSMA?

Bacteria, parasites, and other foodborne pathogens make 48 million Americans sick each year. And the nature of today’s global economy means that the food Americans eat could be grown in one state or country, processed in another, then distributed nationwide. By the time an outbreak of E. coli, listeria, or another foodborne disease is identified, hundreds – or even thousands – of consumers could have purchased food that is potentially contaminated.

With FSMA’s new regulations, the goal is to stop these kinds of outbreaks before they happen. Without proper preventive controls, including mandated food traceability requirements, food businesses risk losing valuable time and money dealing with food recalls that can damage their public image. 

CDC and FSMA

While FDA is the primary U.S. federal agency tasked with implementing FSMA regulations, the law also provides a directive to the Centers for Disease Control and Prevention (CDC). This agency is tasked with improving the collection, analysis, and reporting of data on foodborne illnesses and outbreaks. CDC must also create and manage Integrated Food Safety Centers of Excellence in partnership with state health departments. 

These centers offer technical assistance and training for local health departments, improving their ability to track and trace foodborne disease outbreaks. CDC is also responsible for developing guidelines to manage food allergy and anaphylaxis risks in educational institutions.

When Did FSMA Take Effect?

FSMA was signed into law in January 2011. However, new food safety regulations did not go into effect right away upon passage. Through FSMA, Congress simply authorized FDA to establish food safety requirements for growers, processors, and packers. Implementation of various regulations is ongoing. That means that food businesses must navigate a shifting regulatory landscape as new rules are proposed, finalized, and implemented. 

Food Safety Modernization Act Compliance

Under FSMA, FDA has the authority to create and enforce policies through the federal rulemaking process. To date, FDA has finalized nine major rules concerning food production, traceability, transportation, and more. The FSMA guidelines also give FDA new authority to inspect facilities that manufacture, process, or store food for consumption, both in the U.S. and abroad.

The Food Safety Modernization Act Regulations

FSMA’s regulations affect each step of the food chain from field to fork. Per the administrative rulemaking process, federal agencies must publish a proposed rule, then accept and review feedback during a public comment period. The agency may make changes to the final proposed rule based on these comments. Once an agency publishes a final rule in the Federal Register, it typically goes into effect thirty days or more after publication.

FDA’s proposed and final rules and related programs under FSMA include:

  • Agricultural Water
  • Accredited Third-Party Certification
  • Food Traceability
  • Foreign Supplier Verification Programs (FSVP)
  • Laboratory Accreditation for Analyses of Foods (LAAF)
  • Mitigation Strategies to Protect Food Against Intentional Adulteration
  • Preventive Controls for Human Food
  • Preventive Controls for Animal Food
  • Produce Safety
  • Sanitary Transportation of Human and Animal Food
  • Voluntary Qualified Importer Program (VQIP)

FSMA Section 204 and the Three Pillars of Traceability 

Section 204 of FSMA is entitled “Enhancing Tracking and Tracing of Food and Recordkeeping.” It has three traceability requirements and instructs the FDA to develop additional recordkeeping requirements for certain foods. Quoting verbatim from the Agency’s website, the FDA must:

  1. Establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods.
  2. Designate foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health.
  3. Publish a notice of proposed rulemaking to establish such additional recordkeeping requirements for the designated foods, to help in tracing such foods.

The Food Safety Modernization Act Impact

The passage of FSMA fundamentally changed FDA’s approach to outbreaks of foodborne illness and risk management. Instead of focusing on responding to outbreaks that have already occurred, FSMA prioritizes taking steps to prevent foodborne illness and cross-contamination on farms and food facilities. The legislation means that food businesses are now subject to:

  • FDA-mandated recalls
  • Facility inspections
  • Updated registration requirements

Additionally, FDA guidelines for food safety empower the agency to review facility records and suspend a food facility’s registration if its products are likely contaminated.

How FSMA Affects the Food Industry

FSMA implements new FDA standards for farmers who grow fruits and vegetables. The Produce Safety Rule applies to any grower with average annual produce sales of $25,000 or more. This rule establishes requirements for:

  • Training for workers who harvest or handle produce
  • Water quality testing 
  • Preventing contamination from on-farm animals and wildlife
  • Sanitizing tools and equipment
  • Recordkeeping

The Produce Safety Rule does not apply to certain fruits and vegetables that are rarely consumed raw, such as beans and potatoes. Furthermore, FSMA does not apply to meat and poultry products, which are regulated by the United States Department of Agriculture (USDA).

How FSMA Affects the Food Supply and Food Facilities

Any food facility that manufactures, processes, packs, or holds food for domestic consumption is required to register with the FDA. This requirement was in place before the passage of the FDA Food Safety Modernization Act. However, FSMA revised this regulation to include:

  • Mandatory registration renewal every two years
  • Explicit assurance in the registration documentation that FDA facility inspections are permitted
  • Additional details on facility activities

The Amendments to Registration of Food Facilities final rule also updated registration requirements to ensure that records are submitted to FDA electronically.

Some of the fresh produce available in U.S. grocery stores year-round is shipped from countries in warmer climates. Recognizing that Americans often consume food that was grown or processed abroad, FDA created a separate final rule on Foreign Supplier Verification Programs (FSVP) that establishes requirements for food producers in other countries. These suppliers must show that their growing, harvesting, or packing practices:

  • Ensure food is not adulterated
  • Provide the same level of public health protection as U.S. suppliers
  • Ensure appropriate labeling for food allergens

These regulations are intended to improve the safety of imported food.

FSMA Preventive Controls and Hazard Analysis

FSMA’s Final Rule for Preventive Controls for Human Food establishes minimum standards for manufacturing, processing, packing, and holding food for human consumption. A separate rule governs the production of animal feed.

Under the preventive controls rule, domestic and foreign food facilities must:

  • Use Current Good Manufacturing Practices (CGMPs) 
  • Create and implement a written food safety plan that includes a hazard analysis 
  • Train employees on food hygiene and safety practices, from handwashing to sanitizing food prep surfaces 

FSMA Compliance and rfxcel

If your business is struggling to implement an effective Food Safety Modernization Act compliance strategy, rfxcel is here to help. Our Traceability System offers a comprehensive, customizable set of solutions to help enact FSMA-compliant preventive controls across all your products and ensure your food safety plan is complete. With rTS, you can:

  • Record product data at each step of the supply chain
  • Access real-time data tracing
  • Audit each pallet, lot, or case of product

Plus, our in-house supply chain experts are well-versed in food safety laws and can provide the technical assistance you need. For more information about compliance management and how we can help you navigate federal food safety regulations, contact rfxcel today.

Compliance Management: Key Challenges and How to Overcome Them

Posted on by rfxadmin

Effective compliance management takes time and effort, but it’s much better to be prepared and prevent problems before they occur. Violating the regulations that govern your industry means you risk losing customers, damaging your reputation, and hurting your bottom line. Fortunately, taking a proactive approach means you can address many of the compliance challenges that companies face. Let’s take a closer look at compliance management systems and their benefits.

What Is Compliance Management?

Companies in any sector must understand and follow the local, state, federal, or international regulations that affect how they do business. Compliance management is the set of tools and procedures that a business uses to ensure they follow the laws that govern its industry. Regulatory requirements may be established by:

  • Government entities
  • Labor unions
  • Trade associations or other industry organizations

For example, pharmaceutical companies have to comply with the U.S. Drug Supply Chain Security Act (DSCSA), whose requirements include product serialization and electronic, interoperable data exchange. Similarly, the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) has specific requirements for traceability and data-sharing.

Why Is Compliance Management Important?

Compliance requirements are often in place to ensure ethical behavior toward customers or competitors. Clear, enforceable regulations set standards for businesses, governments, and civil society organizations.

Failure to adhere to applicable laws or regulations could result in fines, fees, suspension of business operations, revocation of licenses or certifications, or other compliance issues. Thus, many businesses create and establish governance, risk management, and compliance (GRC) programs to minimize their risk.

Three Approaches to Compliance Management

A compliance management solution can vary from simple to complex and must be uniquely tailored to suit an organization’s structure and industry. Three common methods of compliance management are:

Strict, Top-Down Approach

This is the most rigid approach to compliance management. Internal policies are created and implemented by the person or team at the top of the organizational chart. There is no room for flexibility or interpretation. A top-down model is usually needed when the health, safety, and welfare of employees or the people they serve are paramount. For example, a daycare operator must follow all the state and local regulations created to keep minors safe.

Hands-Off Approach

In contrast, a hands-off approach is the most flexible type of compliance management. In this model, leadership may establish compliance standards, but the implementation of day-to-day business processes is handed off to middle managers or other employees.

This approach can work in certain situations. For example, a franchisor that has retail food establishments in different states may be subject to health department inspections in each state. Recognizing that each franchisee is subject to a different set of regulations, they may leave it up to each site manager to implement training or an inspection checklist at their respective franchise.

Shared or Distributed Model

In this approach, compliance activities are shared by employees across the organization. Instead of receiving strict guidelines from a central authority, departments or teams may share the responsibility of creating and implementing compliance activities. Or, the organization may issue a central policy and solicit feedback from employees on what to change or improve. A distributed model can work especially well when companies are implementing newly issued regulations and need feedback from staff on the front lines of their industry.

Compliance Management Challenges

Thoughtful, proactive implementation of compliance measures helps save time and money down the line. But compliance management is not without its challenges, which can include:

  • Evolving regulatory landscape: Whether you’re a startup or a multinational corporation, keeping up with new and changing regulations can be difficult. In an increasingly complex corporate environment, it makes sense that organizations may struggle to stay up to date.
  • Changing working environments: In recent years, more and more businesses have embraced a hybrid work model. While letting employees work from anywhere can help organizations stay nimble, it also exposes them to a new set of cybersecurity risks and HR challenges. 
  • Vendor management: You can’t be an expert in everything. Understandably, businesses often partner with third-party vendors for certain services, whether it’s benefits management, IT support, or legal services. Improper vetting or insufficient due diligence can mean that you end up working with vendors that are out of compliance with your industry requirements.

Pharmaceutical, Food and Beverage, and Cosmetics

Companies in the pharmaceutical, food, and beverage, and cosmetics industries face unique challenges when it comes to compliance management. Consumers need to know that the food they eat, the medicine they take, and the personal care products they use are safe.

Pharmaceutical compliance regulations such as the U.S. DSCSA and the EU Falsified Medicines Directive (EU FMD) are in place to improve patient safety, ensure product integrity, and keep counterfeit drugs out of the supply chain. For the food industry, the Food Safety Modernization Act (FSMA) and guidelines like the Global Food Safety Initiative (GFSI), are in place to make the food supply safer and reduce rates of foodborne illness. Regulations for cosmetics vary widely from country to country, but generally, companies must take steps to ensure their products are safe, have complete ingredient labels, and they can verify their labeling claims. 

Throughout all these industries, regulatory bodies are increasingly looking to improve supply chain transparency and traceability.

Compliance Management Best Practices

Companies can support regulatory compliance through best practices such as:

  • Thorough documentation: When in doubt, document everything, even if it’s not mandated by law. A central document repository makes it easy for employees across the organization to find the information they need and prevent non-compliance.
  • Set data standards: Be sure that you’re meeting the industry standards for high-quality data across all business operations. Inaccurate or incomplete data means you’ll be less prepared for accurate compliance reporting.
  • Education and engagement: Know your industry inside and out. Staying connected with industry associations, participating in continuing education, and attending events and conferences helps the organization stay up to date on industry changes and trends.

How to Create a Compliance Management Program

Whether you’re implementing compliance management at a new business or overhauling an existing compliance program, these steps are critical:

Conduct a Thorough Risk Assessment

Start by assessing internal and external risks that could affect regulatory compliance. Review each department to identify and document potential issues and to collect qualitative and quantitative data that you can compare against regulatory standards.

Establish Corporate Policies and Procedures

Look to industry guidance to help you create an initial draft of your compliance policy. You’ll likely need input from stakeholders across the organization, including IT, HR, legal, financial, and risk management leaders. If you don’t already have a compliance officer in place, you’ll need to appoint (or hire) one.

Communicate the Plan and Provide Training

Once your organization has a final compliance policy, it must be communicated to all staff and board officers. Set aside time for dedicated training on the policy, how to use a compliance checklist, and how to conduct an internal audit. Make sure all staff is familiar with any regulatory changes or new rules for recordkeeping and reporting.

Account for Routine Maintenance

Schedule regular reviews of your organization’s compliance policy to ensure it reflects changes in your industry or business operations. Budget the resources to help your compliance team stay abreast of changes in the industry and new regulations.

Conduct Periodic Compliance Audits

Routine internal audits can help identify potential issues before they snowball. Plus, periodic audits ensure your company is better prepared to respond to inquiries from government or regulatory bodies. If violations or vulnerabilities are discovered through an internal audit, take remediation steps immediately and review existing policies to see if there’s a way to prevent similar problems in the future.

Compliance Management Solutions

In addition to a set of internal procedures, a compliance management solution should include:

  • Auditing tools
  • Ongoing compliance training and education for staff
  • Board and management oversight

Additionally, workflow tools and apps can help organize compliance processes and automate certain tasks, like data analysis.

Compliance Management Systems

Today, many organizations rely on digital tools to streamline their compliance efforts. A well-designed compliance management system (CMS) can:

  • Improve data quality and business analytics
  • Ensure consistency across multiple business locations or branches
  • Make tracking, traceability, and reporting easier
  • Automate routine tasks so employees can focus on other business priorities
  • Minimize an organization’s overall risk exposure

Compliance Management Software

Compliance management software offers a central platform for communicating, overseeing, and documenting compliance activities across an enterprise. We’re committed to improving compliance management through supply chain transparency. With our tailored industry solutions, you can track your supply chain in real-time, no matter where your business is located. rfxcel serves businesses in the pharmaceutical, food and beverage, and consumer goods industries around the world. To learn more about our compliance software solutions or schedule a demo, contact us today.

Antares Vision Group Acquires SmartPoint Technologies

Posted on by rfxadmin

Travagliato (Brescia), May 2, 2023 – Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, has acquired through its subsidiary rfxcel 100 percent of SmartPoint Technologies Ltd (SmartPoint), an Indian software product development company that builds powerful and intuitive software solutions.

SmartPoint, founded in 2010 by three entrepreneurs and headquartered in Chennai, offers diverse services and solutions to clients in more than 30 countries. It helps its customers to enhance their business prospects through software enhancement and development options in the IT arena. In Fiscal Year 2022–23 (year end March), Smart Point had 124 employees in India and Germany, and revenues of approximately €3.9 million, of which about 90 percent were generated with rfxcel.

“We have been working with SmartPoint for many years,” said rfxcel CEO Glenn Abood. “With this acquisition, we are internalizing very skilled and talented people, with exceptional expertise and specific abilities that match our interests. SmartPoint’s software development team has been working together for a long time and their know-how is a valuable asset for Antares Vision Group as we continue to invest in technological development to support our growth and to drive the innovation and digitalization process of supply chains.”

Strategic rationale

      • SmartPoint has proven expertise in pharmaceutical track and trace business verticals, and its software developments are directly implemented within the IT systems of top pharmaceutical companies that are rfxcel customers.
      • Its software development team will support rfxcel’s robust future growth.
      • The acquisition is an opportunity for rfxcel to prioritize software initiatives.
      • SmartPoint has approximately 20 full-time staff whose capabilities could be useful to other AV Group subsidiaries.
      • Having stronger in-house capacity will allow rfxcel to better negotiate with other software development companies for any excess work.
      • The deal prevents rfxcel’s competitors from acquiring the company and its know-how.

AV Group was assisted in the acquisition by Gandhi & Associates as legal consultants and Prakash Kotak for financial due diligence.

For more information, contact rfxcel Senior Communications and Content Manager Garrison Spik at garrison@rfxcel.com.

ABOUT ANTARES VISION GROUP
Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of Euronext; furthermore, from July 2022 included in the Euronext Tech Leaders index, dedicated to leading tech companies with high growth potential. In 2022, Antares Vision Group recorded a turnover of €223 million, operates in 60 countries, employs more than 1.180 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvisiongroup.com.

What is the FSMA Traceability Lot Code and Who Must Comply?

Posted on by rfxadmin

If you read our blog (and we know you do), you’re up to speed on the fundamentals of Food Safety Modernization Act (FSMA) Section 204, including the Food Traceability List (FTL) and the food traceability “Final Rule.” Today, we’re looking at an important part of the regulations — the FSMA traceability lot code — and who must comply.

What is the FSMA traceability lot code?

The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)

A traceability lot code must be assigned when any of the following occur:

      • Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
      • Performing the first land-based receiving of a food obtained from a fishing vessel
      • Transformation of a food

Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”

The FSMA traceability lot code in action: CTEs and KDEs

To fully understand the FSMA traceability lot code, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.

In broad terms:

      • CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
      • KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
      • Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).

A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.

Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).

Do you have to comply? Are you exempt?

The Final Rule does have exceptions to the requirements we’ve discussed above.

Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”

Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.

However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.

Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.

Final thoughts about the FSMA traceability lot code

This is a lot to digest. Online tools are fine, but the better option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.

As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.

Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.

Read more about FSMA:

 

India Track and Trace Regulations: March 31 Deadline for Exports & More

Posted on by rfxadmin

India iVEDA deadline extension link

This year will be a busy one for pharmaceutical compliance as governments around the world continue to roll out their serialization and traceability plans. India track and trace regulations are no exception: There was a deadline in January, there’s one at the end of this month, and another is coming in August.

Let’s take a look at the India track and trace regulations and what the pharma industry has to do to be ready.

January 1: Labeling APIs

As of January 1, 2023, all imported and domestically manufactured active pharmaceutical ingredients (APIs) must be labeled with QR codes “at each level packaging that store data or information.” This is the culmination of a process that began in June 2019, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes on APIs. At that time, DTAB estimated that the regulation would affect approximately 2,500 APIs.

The QR codes must contain 11 data points, including a unique product identification code, the name of the API, and the manufacturing and expiry dates. The QR codes must link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

March 31: Full track and trace and reporting to the iVEDA Portal for exported drugs

For all exported drugs, March 31 is the deadline for full track and trace and reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The rules apply to both small-scale industry (SSI)- and non-SSI-manufactured drugs. The iVEDA portal is used for only registering and reporting exported drugs.

August 1: Barcoding for the Top 300 domestic pharma brands

These rules were originally scheduled to come into force on May 1, but that was pushed back to August 1. The rules stipulate that eight data points must be incorporated into a “Bar Code or Quick Response Code” to be printed on or affixed to the primary packaging, including a unique product identification code (e.g., GTIN), the brand name, and manufacturing and expiry dates.

Final thoughts about the India track and trace regulations

We talked about these regulations in more detail last year. See that article here. As we said then, our team has worked in the India pharma market for many years and understands its complexities, challenges, and benefits. We have offices and experienced staff in the country. Contact us today to learn more about the India track and trace regulations and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can help ensure you comply while maximizing your impact in this huge market.

 

Brazil ANVISA Update: SNCM Status, Medical Device Regulations & More

Posted on by rfxadmin

We thought it was time for a Brazil ANVISA update. News has been sporadic since last September, when the Brazilian Health Regulatory Agency — ANVISA — permanently suspended its contract with DataPrev to develop and manage the country’s National Medicine Control System (SNCM).

Let’s catch up with what’s been happening.

Brazil ANVISA update, Part 1: What happened in 2022?

We’ve been following Brazil’s pharma regulations regularly since the SNCM was established in 2016. There were several delays in the rollout, but as we wrote early last year, the industry was anticipating an April 28, 2022, deadline to comply with the SNCM’s serialization, reporting, and traceability requirements.

However, just before that date, the SNCM was put on hold. Events start to cascade from there:

      • May 12: Law No. 14,338/2022 was enacted. This mandated that manufacturers had to provide digital versions of the printed inserts included in drug packaging. The inserts had to have a QR code linked to a digital version maintained in a database authorized by ANVISA. The law also confirmed that ANVISA intended to have a drug traceability system, but did not stipulate a timeline for implementing it.
      • May 23: ANVISA suspended its contract with SNCM developer DataPrev for 120 days.
      • September 12: ANVISA dissolves its contract with DataPrev, and test and production environments were not accessible. The SNCM is effectively suspended.

In case you need a refresher, the SNCM was going to require every pharma supply chain actor to capture, store, and exchange data electronically. All products were to be labeled with a GS1 2D Data Matrix barcode with five data points:

      1. Global Trade Item Number (GTIN)
      2. A 13-digit ANVISA Medicine Registry Number
      3. A unique 13-digit serial number
      4. An expiration date (in the MM/YY format for human-readable form)
      5. A lot/batch number (up to 20 alphanumeric characters)

For the April 28, 2022, deadline specifically, all prescription medicines had to be serialized; all manufacturers and importers had to have a “serialization plan” in the SNCM portal; and all supply chain stakeholders had to submit product event reports to the SNCM.

Brazil ANVISA update, Part 2: Will the SNCM resume in 2023?

On February 14, 2023, a Brazilian publication called JOTA, which monitors Brazil’s government and whose stated mission “is to make Brazilian institutions more predictable,” published an interview with ANVISA Director-President Antonio Barra Torres.

Torres said “the merits of traceability are still alive,” adding the time was right to resume the discussion about the SNCM. Other key takeaways from the interview included the following:

      • Torres said ANVISA was ready, technologically, to support the SNCM; resumption should be able to occur quickly.
      • He believes big manufacturers and most smaller ones are ready to comply.
      • He expects the World Health Organization (WHO) will inspect the SNCM in 2024; the Pan American Health Organization (PAHO) has also offered to inspect the system.
      • He said traceability data wouldn’t solve drug shortages, but could contribute to mitigation strategies.
      • ANVISA is currently short-staffed and needs to fill about 1,110 positions.

Brazil ANVISA update, Part 3: Medical device regulations

New medical device regulations were supposed to go into effect this month but were put on hold. Here’s the context:

Law RDC 751/2022 was passed September 21, 2022. It included rules for medical device classification and regulatory regimes and replaced two previous laws, RDC 185/2001 and RDC 40/2015. Here are some of the requirements in simple terms:

      • Risk classification of medical devices is consolidated into four levels (low, medium, high, maximum). The classifications rules and medical device definitions generally follow the European Medical Device Regulation (MDR).
      • There are specific classification rules for new technologies, including software as a medical device (SaMD) and nanomaterials.
      • Manufacturers must upload medical device instructions for use to an ANVISA portal.
      • Instructions for use, labels, and ANVISA documentation must be in Portuguese; other documents can be in English.
      • The law includes requirements for Brazilian Good Manufacturing Practices.
      • The law does not apply to vitro diagnostic devices, refurbished devices, and personal medical devices.

At the time we’re writing this, it seems the proposed timeline to comply with the new classification rules will begin next year and end in 2028.

Final thoughts

We’ll continue monitoring what’s happening with ANVISA and the SNCM — the entire global regulatory landscape — so bookmark our blog and check back often.

If you have questions about the regulations, contact us today. Our team in Brazil can walk you through what to expect for 2023 and beyond and demonstrate how our pre-configured and pre-validated solutions take the guesswork out of SNCM compliance. We’ve been ready to go since 2016 and we’re ready to go today.

Understanding Uzbekistan Serialization Requirements: Ensuring Compliance and Efficiency

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The rollout of Uzbekistan serialization requirements will continue on schedule as spring 2023 approaches. Let’s take a look at the requirements, what happened last year, and what to expect for this year’s deadlines in March and May.

What are the Uzbekistan serialization requirements?

Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of the Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

Today, the Uzbekistan serialization requirements apply to seven product categories: medicines; medical devices; tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks. Regulated products must be labeled with DataMatrix codes that include four data points:

      • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
      • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
      • A four-character verification key generated by CRPT Turon
      • A 44-character verification code (i.e., crypto code) generated by CRPT Turon

Product packaging must also have the following human-readable information:

      • GTIN
      • Serial number
      • Expiration date in YY/MM/DD format
      • Batch number or lot number

Key dates in 2022

It’s been a little more than a year since Uzbekistan’s State Tax Committee extended the schedule for the “phased introduction of mandatory digital markings” of pharmaceutical products.

We’re also approaching the 1-year anniversary (April 2) of Resolution No. 149, which established the labeling deadlines for four groups of medicinal products and medical devices. There were two deadlines in 2022:

      • September 1: Products produced with secondary (external) packaging (except for orphan drugs)
      • November 1: Products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)

March and May 2023 Uzbekistan serialization requirements

Resolution No. 149 stipulates two labeling deadlines for March 1:

      • Products and medical products to treat orphan diseases as designated by the Ministry of Health
      • Drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan

As with the 2022 deadlines, it seems that Resolution No. 149 established a grace period for mandatory labeling in two circumstances:

      • Products that were produced domestically within 90 days of these deadlines do not have to be labeled and may be circulated.
      • Products that were imported within 180 days of these deadlines do not have to be labeled and may be circulated.

And on May 1, the law requires full track and trace and aggregation with Serial Shipping Container Codes (SSCCs) on tertiary packaging. A customs aggregation code (AIC) for imported products and aggregation code for locally manufactured products is already required. The AIC has 25 digits: a 14-digit tax identification number (TIN) for businesses or personal identification number (PINFL) for individuals; the date the AIC was generated by ASL BELGISI (6 digits in DDMMYY format); and a random 5-digit security code generated by ASL BELGISI.

Final thoughts

The Uzbekistan serialization requirements mean that pharma companies that want to do business in the country have a long list of items to check off their compliance to-do list, including generating and managing serial numbers, obtaining crypto codes from CRPT Turon, and monitoring packing lines to ensure compliance with the requirements.

The good news is that we can help you navigate the requirements. Contact us today and schedule a short demo of our compliance management solution, which takes the guesswork out of compliance by automatically sending reports to regulators, adapting to changes in laws, and updating your partners. Our digital supply chain experts will help you evaluate your needs and work directly with you to design a solution customized for your business.

And sure to bookmark our blog and check back for more updates about Uzbekistan serialization requirements and requirements in other Commonwealth of Independent States nations and members of the Eurasian Economic Union.

Published Feb. 27, 2023

For a Leading Berry Producer, Antares Vision Group Digitalizes Billions of Products for Tight Supply Chain Oversight and Direct Consumer Connections

Posted on by rfxadmin

The Group’s Supply Chain Transparency solution serializes packages in the field, enabling the use of unit-level data to help ensure customers are satisfied with product quality.

Travagliato (Brescia), January 17, 2023 – Antares Vision Group (EXM, AV:IM), an Italian multinational and a leading provider of track and trace and quality control systems that ensures the transparency of products and supply chains through integrated data management, has successfully piloted a Supply Chain Transparency solution for a prominent berry company. The project entails the digitalization of over 1.5 billion products, empowering the berry producer to protect, support, and communicate with its customers.

Powered by technology from rfxcel, which is part of Antares Vision Group, the Supply Chain Transparency solution package enables data concerning harvested berries to be collected and integrated into a platform that fully controls product safety and quality.

Using Antares Vision Group’s advanced serialization and mobile traceability technologies, the producer scans each individual clamshell to associate berry type, farm, and growing conditions, giving each package a unique digital identity with detailed product information. Consumers can scan an on-package QR Code to take a survey, giving the producer valuable insight into its customers’ impressions of specific berries grown at specific locations. This allows the company to focus on the types of berries consumers like best, and to ensure product quality is maintained at high standards from field to end user.

Glenn Abood, CEO of rfxcel, said the project showcases the technology’s impact and scalability. “We’re really expanding boundaries with this project,” he said. “Our coordination with the berry producer has been greatly rewarding; together, we’ve designed a system that reliably manages billions of products in the first and last mile of the supply chain. It performs these tasks day in and day out, with sub-second scanning times and exacting accuracy.”

Abood added that Antares Vision Group and the producer had discussed other applications for the wide-scale serialization of products, such as using digitalized unit-level data for consumer engagement activities and risk-mitigation strategies.

Abood continued: “Our serialization technologies are opening up entirely new avenues for brand value and benefits, connecting safety, quality, efficiency, and trust. The brand owners have actionable and granular information about consumer preferences, opening new dialogue channels and highly targeted customer interactions. Recall management is another benefit: It’s not necessary to recall every package, only a single clamshell. These advantages are available only with serialized products, which unlock opportunities with the power of unit-level data.”

For further information

Herb Wong, Senior Vice President, Product and Strategy: +1 925 791 3235 / hwong@rfxcel.com

Alessandro Baj Badino, Head of Investor Relations: +39 030 72 83 500 / investors@antaresvision.com

Davide Antonioli, Investor Relator: +39 030 7283500 / investors@antaresvision.com

Federica Menichino, Axelcomm (Press Contact): +39 3496976982 / federica.menichino@axel-comm.it

 

ABOUT ANTARES VISION GROUP

Antares Vision Group is an outstanding technology partner in digitalization and innovation for companies and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection. The Group provides a unique and comprehensive ecosystem of technologies to guarantee product quality (inspection systems and equipment) and end-to-end product traceability (from raw materials to production, from distribution to the consumer) through integrated data management, applying artificial intelligence and blockchain technology. Antares Vision Group is active in life science (pharmaceutical, biomedical devices and hospitals) and Fast-Moving Consumer Goods (FMCG), including food, beverage, cosmetics, and glass and metal containers. As a world leader in track and trace solutions for pharmaceutical products, the Group provides major global manufacturers (over 50% of the top 20 multinationals) and numerous government authorities with solutions, monitoring their supply chains and validating product authenticity. Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from 14 May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA), Antares Vision Group recorded a turnover of €179 million in 2021, operates in 60 countries, employs more than 1,000 people, and has a consolidated network of over 40 international partners. To learn more, please visit www.antaresvision.com and www.antaresvisiongroup.com.

India Track and Trace Requirements Update: APIs, iVEDA, and Barcoding

Posted on by rfxadmin

It’s been a busy year with India track and trace requirements. The Ministry of Health has extended a deadline, announced a new deadline, and released new draft rules concerning key areas of the country’s pharmaceutical regulations.

There are deadlines coming up in the next 6 months, so let’s take a look at what’s happening with these India track and trace requirements..

India track and trace requirements for 2023

The upcoming India track and trace requirements affect three areas of manufacturing: labeling active pharmaceutical ingredients (APIs), reporting, and product labeling for the Top 300 brands. We’ll go in chronological order:

Labeling APIs: January 2023 deadline

Starting January 1, 2023, all imported and domestically manufactured APIs must be labeled with QR codes “at each level packaging that store data or information.” The government says this will help combat falsified drugs.

This is the culmination of a process that began in June 2019, when the Drugs Technical Advisory Board (DTAB) approved a proposal mandating QR codes on APIs. At that time, DTAB estimated that the regulation would affect approximately 2,500 APIs.

The QR codes must contain 11 data points:

      1. Unique product identification code
      2. Name of the API
      3. Brand name (if any)
      4. Name and address of the manufacturer
      5. Batch number
      6. Batch size
      7. Date of manufacturing
      8. Date of expiry or retesting
      9. Serial shipping container code
      10. Manufacturing license number or import license number
      11. Special storage conditions required (if any)

QR codes will also link to a national database with pricing data from the National Pharmaceutical Pricing Authority.

Companies are required to get a GS1 Company Prefix, a unique number that identifies a company as the owner a barcode and the product to which it’s affixed, and a GS1 Global Location Number. GS1 Global Trade Item Numbers will serve as the “unique identification code.”

Reporting to the iVEDA Portal: March 2023 deadline

On April 4, 2022, the Directorate General of Foreign Trade (DGFT) released a public notice that extended to March 31, 2023, the deadline for export reporting to the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal. The change applies to both small-scale industry (SSI)- and non-SSI-manufactured drugs.

The deadline for this requirement has been postponed at least four times, starting in 2018, when India track and trace requirements centered around another reporting portal, the Drugs Authentication and Verification Application (DAVA). As we reported when iVEDA was launched, the deadline was changed from April 1, 2020, to October 1, 2020. It was changed again in April 2021 and, as we’re discussing now, in April 2022.

Draft regulations for barcoding pharma products: May 2023 deadline

On September 5, the Ministry of Health and Family Welfare published draft guidelines for barcoding the Top 300 brands in the country, all of which are named in “Schedule H2” of the announcement. The rules will come into force on May 1, 2023.

The goal of these India track and trace requirements — like so many other regulations around the world — is to combat counterfeiting, diversion, and unauthorized sales. The rules stipulate that eight data points must be incorporated into a “Bar Code or Quick Response Code” to be printed on or affixed to the primary packaging:

      • Unique product identification code (e.g., GTIN)
      • Proper and generic drug name
      • Brand name
      • Batch number
      • Expire date
      • Manufacturer name and address
      • Manufacture date
      • Manufacturing license number

If there is “inadequate space in primary package label,” the codes must be placed on the secondary packaging.

Industry observers have noted concerns with the guidelines, including:

      • QR codes may not be practical for data-dense pharmaceutical labeling.
      • The guidelines may not actually help fight counterfeits, diversion, and unauthorized sales.
      • In order for the eight mandated data points to be readable, labels would have to be unrealistically large — too big to fit on most packages.
      • It’s not clear if 2D DataMatrix codes would meet the requirements for a “Bar Code” in the guidelines.
      • GS1 standards are not required; in fact, they’re not mentioned at all.

To this last point, the initial response seems to point toward a call for GS1 standards: DataMatrix for barcoding, GTINs to identify products, use of two-digit Authentication Identifiers.

Final thoughts

India track and trace requirements are obviously evolving. Expect more changes as the deadlines for APIs, iVEDA reporting, and barcoding get nearer.

But one thing won’t change: India will continue to cultivate its position in the global pharmaceutical industry. Consider these statistics from its Department of Pharmaceuticals 2020-21 Annual Report:

      • The Indian pharmaceutical industry is the world’s third largest by volume and 14th largest in terms of value.
      • It has the second-most FDA-approved plants for generic drug manufacturing outside the United States.
      • It accounts for 60% of global vaccine production.
      • It is the world’s third-largest API market (8% share of global API industry, 500+ APIs manufactured in India, and it contributes 57% of APIs on the World Health Organization’s Prequalified List of APIs).

Our team has worked in the India pharma market for many years and understand its complexities, challenges, and benefits. We have offices and experienced staff in the country. And our signature Traceability System and Compliance Management solution have helped our customers keep up with India track and trace requirements and remain competitive.

Contact us today to lean more about the India track and trace requirements and to arrange a demo. In about 15 minutes, one of our supply chain experts can show you how we can maximize your impact in India.

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