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A Guide to Traceability Lot Codes and Food Safety

Posted on by rfxadmin

Traceability lot codes are small but mighty tools that help to ensure food safety. Today, we’re going to look at traceability lot codes, including how they promote safety in the food industry and the important role they play in the Food Safety Modernization Act (FMSA) Section 204 compliance and securing public health.

What Is a Lot Code?

A lot code is essentially a passport for food products. It’s a unique identifier, usually a sequence of numbers and letters, that identifies a specific batch of products that were manufactured (or harvested) under the same conditions and in the same location. Lot codes help track products through the entire supply chain and are vital for troubleshooting quality issues and speeding recalls. Lot codes are assigned to products by the manufacturer.

Whether it’s a pallet loaded with cases of olive oil, a box of cereal, or even a raw agricultural commodity (RAC), the lot code tells you where an item came from and when it was made. This is vital for traceability, helping manufacturers and regulators such as the FDA and USDA keep tabs on products as they move from field to factory to consumers.

Using lot codes not only helps food companies comply with traceability and food safety regulations — they also promote supply chain transparency as part of an indelible provenance that tells where a food came from, who handled it (e.g., harvesters, packers, shippers, and receivers), and its expiration date.

How to Read a Lot Code on a Product

Typically, a lot code includes information about the production date, batch number, and sometimes even the manufacturing line. For instance, a lot code reading “20210305” could mean the product was manufactured on March 5, 2021. If it says “2021030515,” it could mean the product’s expiration date is March 15, 2021. Other numbers can indicate a unique product ID or the name of the grower, producer, or manufacturer.

Role of Lot Codes in Traceability

In the journey from farm to fork, lot codes act like breadcrumbs. They enable traceability at every step, from production to first land-based receiving interactions and beyond. If there is a foodborne illness outbreak or other problem, stakeholders can trace goods back to their sources.

And as we said above, they help you comply with food regulations, including the Food Safety Modernization Act (FSMA), which mandates recordkeeping and traceability requirements for certain foods. More on that below.

Ensuring Food Safety Through Lot Codes

Traceability lot code requirements, such as those in FSMA 204, promote better food safety and transparency across the supply chain. One of the biggest benefits of traceability lot codes is that they help companies and investigators quickly pinpoint  the origins of foodborne illnesses.

If an issue occurs with one of your products, you can quickly determine which products have been affected and where they are in your supply chain or, if they’ve reached their final destination, what retail establishment they’re in. With this granular data, you can implement a focused recall strategy that protects consumers and public health while minimizing product loss. Such precision also helps protect your brand: You can communicate with consumers about the status of the recall, affected areas, and how to dispose of the recalled product.

Common Questions About Traceability Lot Codes

Let’s consider a few common questions about traceability lot codes.

Can a Lot Code Tell You Whether a Product Is Organic or Not?

Lot codes don’t directly convey this information; however, they can be used alongside other product details to let consumers know if a product is organic.

How Can Consumers Use Lot Codes?

Consumers can use lot codes to make informed decisions about the food they buy. They can check the lot code to determine whether their product is part of a recall. It’s also a handy way to gauge a product’s freshness.

Why Are Lot Codes Important for Food Safety?

Lot codes make tracking and tracing products faster, easier, and more accurate. If there’s a problem with a food item, such as a contamination issue, the codes help quickly identify which products are affected.

Consumer Awareness and Lot Codes

If you want to establish your brand as transparent and customer-centric, you should educate consumers about traceability lot codes. Teaching consumers how to read codes and learn what information they provide will empower them to make informed choices regarding the food products they buy.

The FSMA Traceability Lot Code

The Food and Drug Administration’s (FDA) Food Safety and Modernization Act (FSMA) is the primary set of regulatory requirements governing the use of a lot code on food products. FSMA rules outline when to put a lot code on food products, what traceability data you must retain, and more.

The FDA Food Safety Modernization Act requires you to track key data elements (KDEs) and critical tracking events (CTEs) for certain foods like shell eggs, butter, tree-borne fruits, and more. The final rule’s requirements have a compliance date of January 20, 2026. However, some aspects are already being enforced.

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.”

FSMA Traceability Lot Codes in Action: CTEs and KDEs

To fully understand FSMA traceability lot codes, 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 Traceability Lot Codes

This is a lot of information to digest, especially the FSMA requirements. The best 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:

 

Antares Vision Group, Through rfxcel, Begins Partnership with Renown Health Network for DSCSA-Compliant Pharmaceutical Tracking

Posted on by rfxadmin

rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.

Reno, Nevada, March 8, 2023 — Antares Vision Group (EXM, AV:IM), a leading provider of track and trace and quality control systems, today announced that rfxcel, which is part of the Group, has begun a partnership with Renown Health Foundation to implement compliance software so the network can track and trace pharmaceuticals in compliance with the Drug Supply Chain Security Act (DSCSA).

With rfxcel’s DSCSA compliance solutions, Renown Health’s medical groups and pharmacies will achieve real-time electronic tracing of drug products at the package level to identify and trace prescription drugs as they are distributed throughout the health system. This will enhance Renown’s ability to help protect patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

“Reno has been our home since 2018 and many of our employees live and work in the northern Nevada region,” said rfxcel CEO Glenn Abood. “Renown is one of the leading not-for-profit healthcare organizations here and is the perfect partner to team with to give back to our community. We are excited about the opportunity to work with them and to help improve the health and well-being of our friends and neighbors.”

“Ensuring our patient’s medications are safe and legitimate is of the upmost importance to us,” said Renown’s Vice President of Pharmacy Services Adam Porath. “When members of our community get involved in our work, it brings us all closer together. We are thankful that Antares Vision Group and rfxcel are partnering with us on our healing mission. They are making it possible for us to keep our patients safe, comply with the demanding DSCSA requirements, and respond quickly to changing supply chain requirements.”

For further information, write us at news@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 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.

ABOUT RENOWN HEALTH

Renown Health is Nevada’s largest, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe, and northeast California. With a diverse workforce of more than 9,000 employees, Renown has fostered a longstanding culture of excellence, determination, and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the locally owned not-for-profit insurance company, Hometown Health. Renown is currently enrolling participants in a community-based genetic population health study, the Healthy Nevada Project®.

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

Posted on by rfxadmin

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

FSMA Traceability: A Comprehensive Guide for Food Industry Compliance

Posted on by rfxadmin

The Food Safety and Modernization Act (FSMA) is the most significant development in food industry traceability. One specific set of requirements in the law, the Final Rule on Requirements for Additional Traceability Records for Certain Foods, is reshaping and modernizing the approach to food safety and food supply chain data.

Whether you’re a grower, processor, distributor, or retailer in the food industry, understanding and implementing FSMA traceability is vital. Let’s walk through FSMA traceability requirements so you can adapt to the FDA’s Food Traceability Final Rule and ensure your compliance.

What Is FSMA Traceability?

FSMA traceability refers to the ability to track every step of a food product’s journey from farm to table, as required by the law. It’s primary goal is to help prevent and mitigate foodborne illnesses

FSMA traceability requirements center around creating, maintaining, and sharing a clear record of where food comes from, where it was, where it is now, where it’s going, and who’s handling it. 

Under FSMA, the Food Traceability Final Rule defines additional recordkeeping requirements all those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), which includes cheeses, shellfish, and certain fruits and vegetables. It provides you and your trading partners with clear guidance on what data you must keep and share as your products move across your supply chain.

The FDA’s Role in FSMA Traceability

The Food and Drug Administration plays a pivotal role in FSMA traceability: It sets FSMA traceability requirements, evaluates foods using a risk-ranking model, and holds stakeholders accountable for complying with the act. In addition to setting traceability recordkeeping requirements, the FDA also assesses penalties for non-compliance with the traceability program.

Compliance Requirements for Food Industry Professionals

FSMA 204 and other provisions of FSMA apply to:

  • Harvesters
  • Coolers
  • Packers
  • Processors
  • Distributors
  • Retail food establishments

The specific requirements for your business will vary based on your role in the food supply chain. Many requirements focus on initial packing and labeling; proper packaging and labeling promote FSMA traceability and streamline the flow of goods along the supply chain.

FSMA 204 also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Benefits of FSMA Traceability

Embracing traceability promotes better food safety and protects consumers from foodborne illnesses. If an issue arises with one of your products, you can use traceability data to quickly find where it came from and where it is now. This granular, read-time information expedites recalls and ensures that all affected products are removed from store shelves as quickly as possible.

From a business perspective, FSMA 204 helps you protect your brand image, as you can ensure the quality, integrity, and safety of food products. In addition to enhancing your reputation, you can use FSMA traceability to identify bottlenecks within the supply chain and eliminate waste.

Technology and Tools for FSMA Traceability

FSMA gives the FDA the authority to establish modern, science- and risk-based requirements, including all the traceability requirements in Section 204. 

The law dovetails with the Agency’s New Era of Smarter Food Safety, which is “a new approach to food safety, leveraging technology and other tools and approaches to create a safer and more digital, traceable food system.” It will the FDA identify ways to further its modernization goals and help ensure that the regulations evolve with the industry and available technology to reduce foodborne illness.

So, what we’re seeing with FSMA 204 is part of the FDA’s plan to secure the food supply chain using technology. FSMA traceability, anchored by requirements for food companies to record and share Critical Tracking Events (CTEs) and Key Data Elements (KDEs), is attainable with currently available digital supply chain technology. 

Other requirements, such as using traceability lot codes and having systems to share electronic sortable spreadsheets with traceability information to the FDA, are also part of a strategic approach to leveraging technology for FSMA compliance.

Food supply chain traceability software is the best road to meeting technological requirements and FSMA compliance. It’s also the best way to ensure you remain compliant and competitive as regulations, food trends, and consumer attitudes evolve. 

Common FSMA Traceability Challenges 

Challenges to complying with FSMA traceability regulations include the following:

  • Integrating traceability systems with existing processes: Adding any new tech tool to your established systems/process could disrupt operations, including interactions with trading partners.
  • Ensuring your partners are preparing: Traceability requires participation from everyone in the supply chain. Talking with your trading partners about FSMA readiness is vital to being ready to comply by the January 2026 deadline.
  • Training staff: You’ll need to educate and train staff on FSMA 204 compliance and the effect it will have on your business. Training is also necessary to create a culture of food safety in your organization.
  • Managing data: Complying with FSMA means you will be creating, sharing, accessing, and storing massive amounts of data. Your systems not only have to handle the volume — they must ensure the data is compliant.

Navigating the challenges requires a holistic approach. First and foremost, you need to get your team on board by being transparent about the regulations, how they will affect your daily operations, people’s roles and responsibilities, and what you are doing to prepare. 

The Importance of Data Security and Privacy

With so much sensitive data being generated, security and privacy are paramount. You need to make sure that your traceability data is protected from unauthorized access and breaches. This means investing in secure systems and being mindful of privacy laws and regulations.

Additionally, you must ensure that your partners are doing their part to promote data security. Remember, you’ll need to integrate some of your technologies with theirs to expedite the flow of traceability data. You don’t want to inadvertently create a blind spot or weak link in your data infrastructure by partnering with a vendor that does not take data security as seriously as you do.

Anticipating Regulatory Audits

Nobody wants to be audited, but everybody should be prepared. The key to passing an audit is to make food safety and FSMA compliance part of your company culture. If these are only afterthoughts or simply a box to check, the chances of failing an audit are much higher. In contrast, being proactive means an audit will essentially be a formality (and become an opportunity to stand out among competitors).

Final Thoughts: FSMA Traceability with rfxcel

Familiarizing yourself with FSMA traceability requirements will help you achieve and maintain compliance, improve food safety, and preserve your brand image. Prioritize compliance and implement effective traceability practices by partnering with rfxcel. We’ve been a leader in traceability (and compliance) technology for 20 years, and we will work with you to develop a solution suited to your needs.

Book a demo to learn more. We also invite you to explore our other FSMA resources.

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.

rfxcel Is Now Antares Vision Group Supply Chain Visibility Solutions

Posted on by rfxadmin

The company will enhance supply chain transparency in diverse industries by leveraging its proven technologies and Antares Vision Group’s unique ecosystem of L1-L5 solutions.

Reno, Nevada, December 1, 2022 – rfxcel today announced that it is now Antares Vision Group Supply Chain Visibility Solutions. The company will continue as a leader in digital supply chain solutions while being bolstered by other Group members and their expanding global presence.

Glenn Abood, who co-founded rfxcel in 2003, will continue as CEO and is a part of the Group’s Governing Board. He said there will be no internal organizational changes, and that customer operations and support will continue as before.

“The main message, other than excitement about the evolution of our company, is one of continuity,” he said. “Continuity in every facet of our work, but with one significant difference: We have the full force of Antares Vision Group’s unique ecosystem of L1-L5 solutions. This means more options, flexibility, and possibilities for our customers. It means more technologies and capabilities in more industries and countries. It also means that Antares Vision Group is the undisputed leader in end-to-end supply chain solutions.”

rfxcel entered into an acquisition agreement with the Group in February 2021. As Antares Vision Group Supply Chain Visibility Solutions, it will continue bringing excellence and best-in-class solutions to diverse industries, including life sciences, food, beverage, cosmetics, and fast-moving consumer goods. For more information, contact Senior Communications and Content Manager Garrison Spik at garrison@rfxcel.com.

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About Antares Vision Group

Antares Vision Group is an outstanding technology partner in digitalization and innovation for enterprises and institutions, guaranteeing the safety of products and people, business competitiveness, and environmental protection.

The Group provides a unique and comprehensive ecosystem of technologies — including software and hardware — to guarantee product quality (inspection systems and equipment) and end-to-end traceability (from raw materials to production, from distribution to the consumer), through integrated data management, applying artificial intelligence and blockchain too.

Antares Vision Group is active in the life sciences (pharmaceuticals, biomedical devices, and hospitals), beverage, food, and cosmetics industries, and is expanding into other sectors. The world leader in track and trace systems for pharmaceutical products, it provides major global manufacturers and numerous government authorities with solutions to monitor their supply chains and validate product authenticity.

Listed since April 2019 on the Italian Stock Exchange in the Alternative Investment Market (AIM) segment and from May 2021 in the STAR segment of the Mercato Telematico Azionario (MTA) (electronic equity market), Antares Vision Group operates in 60 countries, employs approximately 1,000 people, and has a consolidated network of more than 40 international partners. antaresvisiongroup.com

About Antares Vision Group Supply Chain Visibility Solutions

Antares Vision Group Supply Chain Visibility Solutions has a long history of providing leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust the company’s technology to power end-to-end supply chain solutions in track and trace, transparency, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States.

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.

Join Antares Vision Group at the HDA 2022 Traceability Seminar in October

Posted on by rfxadmin

Antares Vision Group will be at the HDA 2022 Traceability Seminar October 12-14 at the Marriott Marquis in Washington, D.C. We’re an official sponsor, and our team will be there with our latest technologies and solutions. Stop by to meet us!

The HDA 2022 Traceability Seminar brings together healthcare supply chain leaders to learn more about implementation milestones of the DSCSA as distributors, manufacturers, and dispensers implement serialization and traceability technologies.

Attendees also discuss innovative approaches and lessons learned from the first 9 years of the DSCSA rollout and what to expect during the “last mile” of implementation until the November 2023 deadline.

Get the latest DSCSA intel from our experts at the HDA 2022 Traceability Seminar

If you’re reading this, chances are you know that we’ve been leading on the DSCSA since Day 1 and have collaborated with the pharma industry to test key systems, work out kinks, and help all stakeholders prepare. Here are just a few examples:

And it should come as no surprise that Herb Wong, our SVP of product and strategy, will be at the Seminar. He’ll be at our booth, of course, but he’s also doing the “EPCIS Onboarding Across the Supply Chain” panel discussion on Thursday, Oct. 13, from 1:30 to 2:30 p.m.

Herb will also host a Friday morning roundtable about DSCSA readiness. Antares Vision Group is sponsoring the day’s Roundtable Discussions (9:35-10:50 a.m.), where you can discuss operational issues associated with traceability implementation. Choose a topic that interests you and rotate through the tables with your peers. Highlights from the discussions will be shared at the end of the session.

With this experience and knowledge, our team wants to answer your questions and show you our solutions while you’re at the Seminar. No matter how far along you are in your DSCSA preparations, time with our team will be time well spent — informative, interesting, and maybe even game-changing.

Final thoughts

We’re just a year away from the final DSCSA deadline and the full serialization of the U.S. pharmaceutical supply chain. The HDA 2022 Traceability Seminar is really the place to be when it comes to the “right now” of the DSCSA for product identification, product tracing, product verification, and requirements for authorized trading partners.

So bring your DSCSA questions for our team and let us know how things are going. Visit our booth. Sit in on Herb’s Thursday EPCIS panel discussion and his Friday roundtable. If you have 3 minutes, take our DSCSA Readiness Survey. You can also check out our DSCSA Compliance Library for all of our resources about the law.

We hope to see you in October!

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