April 2021 - rfxcel.com
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Month: April 2021

Pharmaceutical Compliance: A Global Overview

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rfxcel continually monitors the regulatory landscape in order to improve our products and customer service and maintain our position as the leader in pharmaceutical compliance. We strive to bring you the most accurate and complete information about news, trends, and other developments at all levels of the pharmaceutical supply chain — local, national, regional, and global.

Updated periodically, our “Pharmaceutical Compliance: A Global Overview” publication summarizes regulations in key markets, from Australia to United Arab Emirates. It provides at-a-glance details about pharmaceutical compliance fundamentals, including deadlines, milestones, barcoding requirements, aggregation, and traceability. We also share links to other helpful information about global pharmaceutical compliance, such as official government agencies and their supply chain regulations and announcements.

Furthermore, we’ve taken the opportunity to include a comprehensive bibliography of our own pharmaceutical compliance resources. We share our white papers, webinars, blog posts, articles in industry publications written by our supply chain experts, and press releases about rfxcel’s accomplishments in pharmaceutical compliance. These resources cover everything from specific regulations (e.g., the EU Falsified Medicines Directive, the U.S. Drug Supply Chain Security Act, and Russia Chestny ZNAK) to more general information about the pharmaceutical supply chain and how to keep it safe and secure.

Food Traceability Regulations in the United States: A Timeline

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The U.S. Food and Drug Administration (FDA) is orchestrating the construction of a more robust, technology-driven approach to food traceability and safety. And it’s happening as the food industry is undergoing major change, including scores of new foods being introduced to the market, rising consumer demand for more information about the food they buy, the development of more sophisticated production and delivery methods, and a growing push for digitization of the supply chain.

As regulations in the United States continue to evolve, manufacturers, wholesalers, distributors, and retailers need to keep a finger on the pulse of the latest developments. Today, we’ll help with a quick rundown of what’s happened with food traceability over the last year.

Food traceability regulations in the United States: 2020-present

On September 23, 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods” on its Food Traceability List. Referred to as the “Food Traceability Proposed Rule,” it’s part of the FDA’s New Era of Smarter Food Safety Blueprint and aims to standardize the data elements and information required to rapidly and accurately identify foods that may be causing illness. It defines additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List, which must establish and maintain records containing key data elements (KDEs) associated with specific critical tracking events (CTEs).

In January 2021, the FDA made clarifying modifications to the Food Traceability List and published a detailed FAQ that answered commonly asked questions that emerged following the announcement of the Proposed Rule. In February 2021, the comments period for the modifications closed. The FDA has until November 2022 to finalize it.

More about the New Era of Smarter Food Safety Blueprint

These initiatives are part of the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it envisions a modern approach to ensuring food safety through digital, tech-enabled traceability.

The New Era of Smarter Food Safety Blueprint, announced in July 2020, outlines the FDA’s methodology for achieving its traceability and safety goals. It’s based on the following four pillars, which leverage a range of technologies, analytics, business models, modernization, and values as its building blocks:

1. Tech-enabled food traceability

A supply chain that includes paper-based recordkeeping and yields insufficient data makes it difficult to track and trace foods rapidly. Fast, accurate food traceability is essential to safeguarding consumers’ health — and your brand reputation and bottom line.

For example, modernized food traceability that leverages the latest technologies and integrates expanding data streams empowers supply chain stakeholders to identify an outbreak and trace a contaminated food product’s origin within minutes — or even seconds — and be proactive about getting the product off of shelves.

2. Smarter tools and approaches for prevention and outbreak response

In addition to better food traceability, the FDA wants to ensure the root cause of an outbreak or contamination can be easily identified to support a prevention-based approach. To do this, stakeholders need to incorporate new knowledge while continuously assessing how they can make processes and communications more effective and efficient. As more data becomes available, the use of predictive analytics tools becomes increasingly important to predict when a significant food event may occur. With this information, manufacturers can prevent a contaminated food products from entering the supply chain or target efforts to remove a potentially contaminated product from the market.

3. New business models and retail modernization

As the industry continues to find new ways to produce and distribute food, the FDA is seeking to explore new approaches in ensuring food traceability and safety. This includes:

  • Educating supply chain actors on the importance of food safety issues
  • Adapting FDA oversight to ensure the safety of novel ingredients, new foods, and new food production methods
  • Advancing the safety of foods sold in traditional retail establishments
4. Food safety culture

The FDA wants to encourage an environment of support for a stronger food safety culture on farms, in food facilities, and in homes. If the food industry does not commit to embracing food traceability and safety, real improvements will be difficult to achieve.

Final thoughts

We can be certain of two things when it comes to food traceability regulations in the United States: they’re going to keep evolving and they’re not going away. The good news is advancements in technology are making it profoundly easier — and even more affordable — to ensure food traceability across the entire supply chain. Yes, the FDA’s proposed requirements technically apply only to items on the Food Traceability List, but the Agency is encouraging voluntary adoption of these practices industry-wide. Savvy food companies will see this as an opportunity to get involved early and be part of the process, helping to set the industry’s regulatory course while going a long way to secure their own business.

rfxcel can help you comply with U.S. food traceability regulations today, tomorrow — always. From raw ingredients to finished goods, our rfxcel Traceability System (rTS) offers end-to-end food supply chain traceability and visibility. Our rfxcel Integrated Monitoring (rIM) is a real-time traceability and supply chain visibility solution that helps you remotely monitor products in transit And our MobileTraceability app brings the power of rTS to every node of your operations, including places that have traditionally been “blind spots.” Contact us today to arrange a demo.

DSCSA 2023: Unlocking the Future of Pharmaceutical Traceability in the USA

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Welcome to the third and final installment of our DSCSA 2023 series. The first two parts talked about DSCSA authorized trading partners — manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers. If you’re not a DSCSA authorized trading partner, it will be difficult to do business in the United States, so be sure to read Part 1 and Part 2.

Today, we’re focusing on the day we’ve all been preparing for: November 27, 2023, the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act):

“On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.”

So, in a little more than 2 years and 8 months from now, the U.S. pharmaceutical supply chain will be fully serialized. Let’s take a closer look at what this means for the pharma industry and its authorized trading partners.

A quick clarification

This blog post looks at “the letter of the law” — the language in Section 582(g)(1) that lays out six requirements for DSCSA 2023.

For its part, the pharma industry has tended to see the DSCSA as having four pillars, as illustrated below. These pillars encompass the six requirements we’re talking about today.

DSCSA 2023 Four Pillars

Our own Herb Wong, VP of marketing and strategic initiatives, recently hosted a webinar about DSCSA 2023 readiness that included an overview of the four pillars. It’s a great follow-up to what you’ll read below and a valuable resource for every pharma supply chain stakeholder. If you missed it or want to watch it again, Herb’s webinar is here.

DSCSA 2023: six key requirements

To date, the DSCSA has focused on lot-level traceability, or exchanging information about every package of medication so supply chain stakeholders can see exactly where each has been. DSCSA 2023 is all about complete unit-level serialization through the use of product identifiers, meaning stakeholders will have to electronically track products at the individual package level. Here are the six requirements for DSCSA 2023 laid out in Section 582(g)(1):

  1. Authorized trading partners must exchange transaction information (TI) and a transaction statement (TS) in a secure, interoperable, electronic manner.

TI includes the product name; its strength and dosage form; its National Drug Code; container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred. The TS is an attestation by the business transferring ownership of the product that it has complied with the DSCSA.

Trading partners must maintain all transaction data for 6 years.

The law requires the standards for interoperable exchange of TI to “comply with a form and format developed by a widely recognized international standards development organization.” Right now, EPCIS 4 (Electronic Product Code Information Services) is the only standard that meets this requirement; however, the industry is investigating alternatives.

  1. TI must include the product identifier (PI) at the package level for each package included in the transaction.

The upshot of this requirement is unit-level traceability (i.e., serialization). A PI is a standardized graphic that contains the product’s standardized numerical identifier (SNI), a lot number, and an expiration date. The SNI comprises two data points: the National Drug Code and a unique alphanumeric serial number. PIs must be human- and machine-readable.

  1. Authorized trading partners must have systems and processes to verify products at the package level, including the SNI.

According to the definition in Section 581 of the DSCSA, “verification” or “verify” means determining if the PI “affixed to, or imprinted upon, a package or homogeneous case corresponds to the SNI or lot number and expiration assigned to the product by the manufacturer or the repackager.”

  1. Authorized trading partners must have the systems and processes to promptly respond with the TI and TS for a product upon a request by the Secretary (or other appropriate federal or state official) in the event of a recall or for the purposes of investigating a suspect or illegitimate product.

The “Secretary” here is the commissioner of the U.S. Food and Drug Administration (FDA). Suspect and illegitimate products include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.

This requirement dovetails with the FDA’s push for modernization of the U.S. food supply chain, including recall processes.

  1. Authorized trading partners must have the systems and processes necessary to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.

This requirement is similar to No. 4 in that authorized trading partners must provide this information to the FDA commissioner or other federal or state officials; however, goes a step further by adding trading partners. The law says these systems and processes

“shall be required in the event of a request by an authorized trading partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a suspect product or assisting the Secretary (or other appropriate Federal or State official) with a request described in clause.”

  1. Each person accepting a saleable return must have systems and processes in place to allow acceptance the product(s). Furthermore, they may accept saleable returns only if they can associate the returned product(s) with its TI and TS.

This has to do with the DSCSA saleable returns verification requirement and the Verification Router Service (VRS). Supply chain stakeholders must verify saleable returns before they can be reintroduced to the supply chain; they do this by verifying the drug’s PI. The VRS is the system they use to rapidly verify PIs.

rfxcel is the industry leader in the VRS. We led an FDA-approved pilot to extend testing of the VRS and continue to focus on making it ready for DSCSA 2023. Here a few of our resources to answer any questions you may have:

Final thoughts

As we said in Part 1, we’ve been covering the DSCSA for a long, long time. We’ve done webinars, written white papers, and been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet the requirements for DSCSA authorized trading partners.

We’ve also been helping pharma companies comply with the DSCSA and other pharma regulations around the world. From our rfxcel Serialization Processing and Compliance Management solutions to the full-scale power of our rfxcel Traceability System, we ensure compliance no matter your role in the supply chain.

So contact us with your questions about DSCSA 2023 or the DSCSA in general. Our supply chain experts can give you a short demonstration of our solutions, share their insights and knowledge, and work with you to ensure you’re compliant today, tomorrow — always.

 

 

 

 

 

 

Requirements for Russia’s Textile and Apparel Supply Chain

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There’s always something interesting going on with Chestny ZNAK, Russia’s National Track and Trace Digital System. (Well, we think it’s interesting, and chances are you do too if you’re reading this.). Adjustments, pilots beginning and ending, mandatory product labeling going into effect … it’s a treasure trove of track and trace. Such is the case with today’s topic: Russia’s textile and apparel supply chain.

Technically, Chestny ZNAK refers to some facets of the textile and apparel supply chain as “clothing items and light industry goods.” The category includes coats, shirts, blouses, and linens.

Globally, footwear and some items made with fur are certainly part of the textile and apparel supply chain. Chestny ZNAK, however, treats these as separate categories, so we’re not including them in today’s discussion. We’ve written about footwear before — mandatory serialization and other requirements went into effect on July 1, 2020 — and you can learn more about requirements for fur (and all regulated product categories) by downloading our “Overview of Chestny ZNAK Compliance for Key Industries” white paper. It’s fully updated for 2021 and available in both English and Russian.

Okay, let’s get into clothing items and light industry goods in Russia’s textile and apparel supply chain.

Serialization in Russia’s textile and apparel supply chain

A pilot for clothing/light industry products was conducted during the second half of 2019, and mandatory labeling began on January 1, 2021. To date, Chestny ZNAK reports that more than 130,000 textile and apparel supply chain stakeholders have been issued more than 1.4 billion marking codes.

All products must be labeled with a DataMatrix code containing four data points:

  • A 14-digit Global Trade Item Number (GTIN)
  • A 13-digit serial number
  • A 4-digit verification key
  • A 44-digit verification code (i.e., crypto code)

The Center for Research in Perspective Technologies (CRPT), which manages Chestny ZNAK, issues verification keys, crypto codes, and serial numbers. Manufacturers, importers, wholesalers, and retailers, referred to as “economic agents,” can also generate serial numbers.

Before economic agents are issued codes, they must create a “product card” for Russia’s catalogue of marked goods. These must note four product attributes

  • The product name
  • The 4-character EAEU Combined Nomenclature of Foreign Economic Activity (TN VED) code
  • The corresponding GTIN
  • The trademark (if any)

New goods produced in Russia must be marked before leaving the factory. For importation from other Eurasian Economic Union (EAEU) countries (Armenia, Belarus, Kazakhstan, and Kyrgyzstan), codes must be applied before the goods enter Russia’s textile and apparel supply chain. For imports from all other countries, codes must be applied before customs processes begin.

Economic agents must have an encrypted digital signature and equipment to handle codes, including scanners, printers, and point-of-sale cash registers connected to the internet (for retail sales).

These are the broad strokes of compliance for the textile and apparel supply chain. For full details, be sure to download our white paper.

Final thoughts

Russia’s textile and apparel supply chain is large and lucrative. But to participate and succeed, you need to be able to navigate Chestny ZNAK’s strict requirements. To do this, you need the right partner, one that knows the regulations, has a local team, and actually has active in-country implementations.

Right off the bat, we can say that we’re the only official CRPT software or integration partner for clothing items and light industry goods. In fact, we’re the only official CRPT partner for several other industries; we’ve proven that our signature rfxcel Traceability System integrates seamlessly with Chestny ZNAK and meets regulatory requirements for key industries. We were also recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.

To learn more about our leadership in Russian supply chain compliance, check out these recent blog posts:

If you have questions about the textile and apparel supply chain in Russia — or any other market where you’re doing business or want to do business — contact us today to schedule a demo. See how our powerful software can ensure you’ll remain compliant with textile and apparel supply chain regulations around the world.

 

Mandatory Dairy Product Labeling in Russia to Begin in Two Months

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It’s going to be a busy year for dairy product labeling in Russia. (If you missed our earlier overview, be sure to check it out.) In fact, it’s going to be a busy year for product labeling in Russia generally. A quick look at our blog reveals that the National Track and Trace Digital System, or Chestny ZNAK, is not relenting on its goal of transforming Russia’s supply chain by 2024:

But let’s stay focused on dairy product labeling, which is scheduled to commence on June 1 for two product categories, then will be phased in for two other categories later in the year.

Dairy product labeling in Russia: background

The Chestny ZNAK pilot for dairy product labeling from July 15, 2019, to December 31, 2020. The dairy supply chain has a unique configuration because Chestny ZNAK will share track and trace duties with the “Mercury” electronic veterinary certification system, which tracks animal products in Russia.

Dairy product labeling requires a DataMatrix code containing four data points: a 14-digit Global Trade Item Number (GTIN), a 13-digit serial number, a 4-digit verification key, and an expiration date.

Other dairy product labeling requirements include the following:

  • Product packaging must have a blank field up to 15×15 mm to accommodate the DataMatrix code.
  • Caps on PET bottles must be able to accommodate either printing or labeling with a laser.
  • Manufacturers can have unusually shaped cartons or bottles tested to determine if the form factor affects dairy product labeling and scanning accuracy/reliability.
  • Aggregation is required; the parent-child relationship must be maintained between the aggregation and the individual units within it.

If you want to learn more about Russian dairy product labeling, download our “Russia Chestny ZNAK and the Dairy Industry” white paper. It’s fully updated for 2021 and really drills down into the details.

While we’re at it, if you want to learn about product labeling and serialization for all of the industries regulated in Russia, download our “Overview of Chestny ZNAK Compliance for Key Industries.” This is also fully updated for 2021 and is our most comprehensive publication about Russian supply chain compliance.

The June 1 dairy labeling requirements

Mandatory dairy product labeling begins June 1 for cheeses and ice cream and other edible ice with or without cocoa. Only serialized products can be sold after this date. However, products produced or imported into Russia before June 1 may be sold until the product’s expiration date.

Companies were permitted to begin labeling these cheese and ice cream products as early as January 20, 2021. They were also allowed to transfer dairy product labeling data to the Government Information System for Marking (GIS MT), which catalogs all labeled goods in Russia’s supply chain. To transfer data to GIS MT, you must be registered with Chestny ZNAK.

The table below shows Russia’s product classification codes (OKPD2) and the corresponding Eurasian Economic Union (EAEU) Combined Nomenclature of Foreign Economic Activity (TN VED) codes for labeling these products. This information comes from Chestny ZNAK.

Russia Dairy Product Labeling

 

Final thoughts

rfxcel is the leader in Chestny ZNAK compliance. Not just for dairy product labeling — for labeling requirements in all regulated industries. We know these regulations can be tough to decipher. To help, we have useful resources, like the stories we linked above, our Chestny ZNAK refresher course, our white papers, and our webinars.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy product labeling requirements is to talk with us directly. When we say we’re the leader in Russian compliance, consider our credentials:

  • We’re an official integration, software, and tested solution partner with the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK.
  • We were recently accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year.
  • Our Moscow-based team provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

We’ve also demonstrated that our solutions, including our signature rfxcel Traceability System (rTS), Compliance Management (rCM), and Serialization Processing (rSP), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant. In fact, we had to prove this to the CRPT to be named an official partner. rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.

So contact us today learn more about how we can help you with dairy product labeling and other Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures companies in any industry remain compliant with Russia’s complex regulations.

 

 

 

 

Russia Chestny ZNAK Bottled Drinking Water Pilot Ending Soon

Posted on by rfxadmin

A year ago today — April 1, 2020 — Russia started its Chestny ZNAK bottled drinking water pilot. Chestny ZNAK is Russia’s National Track and Trace Digital System, which is transforming how the country runs and regulates the supply chain for everything from pharmaceuticals to fur. It’s managed by the Center for Research in Perspective Technologies (CRPT).

If all goes as planned, the Chestny ZNAK bottled drinking water pilot will wrap up on June 1. Let’s take a quick look at the pilot and what we can expect going forward.

The Chestny ZNAK bottled drinking water pilot

As we said, the pilot (or “experiment,” as these projects are called in Russia) began on April 1, 2020, and is scheduled to end just two months from now, on June 1. The bottled drinking water category includes mineral and carbonated waters, waters without sweeteners or other flavoring, and non-carbonated water. The table below shows the Eurasian Economic Union Combined Nomenclature of Foreign Economic Activity (TN VED) code for the products that must be labeled, as provided by Chestny ZNAK.

 

BOTTLED DRINKING WATER

Pilot: April 1, 2020–June 1, 2021

TN VED CodeDescription
2201Beverages and spirits and vinegar: waters, including natural or artificial mineral waters and aerated (i.e., carbonated) waters, not containing added sugar or other sweetening matter nor flavored; ice and snow

 

Like pilots for other industries, the Chestny ZNAK bottled drinking water pilot tests end-to-end tracking and tracing of marked goods from manufacturing sites or import/customs locations to final sale to consumers. It’s also designed to determine the best approaches for marking and tracing products, including testing methods of applying codes to different types of packaging, such as PET bottles and bottles with irregular shapes.

Chestny ZNAK, which is now in its fourth year of operation, generally requires products to be labeled with a 2D DataMatrix code containing four data points: a Global Trade Item Number (GTIN), a serial number, a verification key, and a verification code (i.e., crypto code).

The DataMatrix codes being used in the Chestny ZNAK bottled drinking water pilot must contain three data points: a 14-digit GTIN, a 13-character serial number, and a 4-character verification code. An optional fourth data point can include information such as the minimum retail price and expiration date. Product packaging is required to have a blank field up to 15×15mm to accommodate the code.

The pilot’s goals include the following:

  • Supply chain actors order DataMatrix codes and apply them to products.
  • All labeling information is transferred electronically to Chestny ZNAK.
  • Products in shipping packages are aggregated; codes for each unit in the aggregation are also aggregated.
  • Marked products enter circulation.
  • Products are tracked and traced in the supply chain, and stakeholders exchange Universal Transfer Documents (UTDs) to record transfer of codes.
  • Consumers purchase goods, which are withdrawn from circulation at checkout via point-of-sale cash registers and scanning devices.

Final thoughts

The CRPT has not announced when mandatory marking of bottled water products will begin. If the pilot ends on schedule, there will likely be a final report and review period, so it could be late 2021 or even early 2022 before you’ll have to comply.

Regardless, the time to think about compliance is now. If you want more details about the Chestny ZNAK bottled drinking water pilot — or any of the regulated industries — start by downloading our white papers. We’ve updated all of our Russia white papers for 2021 and included even more details about what you need to know and do to be compliant.

You should also contact us. We’ve been prepared for Russia’s regulations since 2018. Here a just a few of the reasons why we’re the leader in Chestny ZNAK compliance:

  • We are an official software and integration partner of the CRPT.
  • We’re accredited as an IT company by the Ministry of Digital Development, Communications, and Mass Media.
  • We are one of only a few providers with in-country implementations; clients include global consumer goods and pharma companies.
  • Our powerful software ensures companies in any industry will remain compliant while mastering their supply chains with end-to-end traceability and rich, actionable data mined right down to the unit level.

We’ll be posting more about what to expect with Chestny ZNAK requirements in 2021. There’s definitely a lot going on — including pilots for biologically active food additives and beer getting under way now — so check back often.

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