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Dispensers, DSCSA and 3Ts

The DSCSA for Dispensers will be live by November 2020. U.S. based dispensers will only be able to buy or sell any product that has the 2D data matrix barcode and human-readable text format. rfxcel has launched efforts to educate pharmacists, including web pages, flyers, and webinars about the DSCSA requirements. Download this quick guide to DSCSA Requirements for Dispensers. If you want more info about your specific needs, please contact us here.

Russia Serialization for Pharma

This Russia serialization guide and white paper look at the massive changes coming to Russia’s supply chain, due to be completed by 2024. The transformation, designed to keep fake and substandard products out of the market, will have a huge impact on the pharmaceutical industry. For example, manufacturers and distributors must connect and comply with the National Track and Trace Digital System, Chestny ZNAK. All medications, including OTC medications, must be serialized, and there are special requirements regarding aggregation and separate serialization requirements for batches. Access this concise, easy-to-understand resource about the Russian pharma regulations.

For any other questions please reach out to our local experts:

Russia:
Victoria Kozlova
Director of Operations
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P: +7 985 7504284

USA:
Brian Bilyeu
VP of Sales
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P: +1 925 824 0300

Europe:
Simon Manley
Commercial Director
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P: +44 1223 926923

Latam:
Vinicius Bagnarolli
Commercial Director
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P: +55 11 97148 7826

India:
Arun Rao
Head of Business Development
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P: +91 982 063 9476

3 Months to DSCSA Serialization Enforcement

With only 3 short months to go, all manufactures and repackagers need to be ready for the FDA’s DSCSA serialization enforcement. Drugs sold in the United States must comply with the FDA’s Drug Supply Chain Security Act (DSCSA) deadline to have item-level serialization affixed or imprinted on unit-of-sale prescription drugs sold in the United States.   

On June 30, 2017, the FDA issued Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informed supply chain stakeholders that the FDA would delay DSCSA serialization enforcement of product identifiers on prescription drug packages and cases until November 2018. This delay provided manufacturers additional time to put in place technology to generate product identifiers and avoid supply chain disruptions.

While product identifiers—commonly referred to as serialization—is the backbone of the DSCSA, it is just one of many requirements. Each node within the supply chain, from manufactures all the way down to dispensers, must meet a unique set of DSCSA requirements. These unique requirements have presented new challenges to companies of all sizes within the drug supply chain. Recently, many of those challenges came to light at a Healthcare Distribution Alliance (HDA) meeting, in which industry leaders exchanged their experiences and the many challenges that still lie beyond the November 27, 2018 serialization deadline.

 

How rfxcel is helping companies get ready for DSCSA serialization enforcement:  

The November 2018 deadline accelerates the need for rfxcel’s traceability solution. In order to achieve full compliance, members of the supply chain including manufacturers and wholesalers all the way down to dispensers need collaborative technologies that track and trace a product, no matter the maker or origin, throughout the supply chain. The DSCSA details how the manufacturer must start the process of tracing a product by producing the transaction history, transaction information, and a transaction statement of the individual batches and units. This information is then passed to each actor within the supply chain to continue the drug history. Serialization is the crux of the effort allowing for the eventual tracing back up the supply chain for returns and recalls.

rfxcel understands the intricacies of the supply chain and how easily a business can be consumed by compliance efforts. This is why rfxcel closely partners with customers to understand their business strategy and objectives without losing sight of regulatory compliance. This is achieved through establishing a clear project structure, open lines of communication, collaboration, approved technical requirements, and a ‘Gold Release’ implementation effort that does not disrupt business operations.

‘Gold Release’ Implementation Plan: 

Larger pharmaceutical companies have been doing serialization for over 15 years. Even still, many of these companies had to adjust to the DSCSA serialization enforcement requirements. In late 2016, a number of these large pharmaceutical companies wrote to the FDA indicating they were facing challenges meeting the serialization deadline. The FDA wisely determined that if these large companies were having issues meeting the deadline, then smaller companies must be having similar issues. The FDA agreed to delay the deadline by one year establishing a new deadline of November 27, 2018.

Based on the issues many companies were having, rfxcel created an express on-boarding plan to expedite pharmaceutical companies’ compliance with the DSCSA. Dubbed the ‘Gold Release,’ rfxcel developed templates and compliance modules for rapid compliance implementation. The ‘Gold Release’ is a repeatable process that enables deployment events to occur faster and trouble free, providing a simple approach to meet compliance while controlling costs and minimizing business impact.

Supported with collaboration:

Historically, while the pharmaceutical supply chain has worked in a stove-piped fashion, traceability paired with the requirements of the DSCSA requires total collaboration across the industry. In that spirit, rfxcel leads collaborative efforts with working groups and classes among industry partners. Transparency and ongoing collaboration ensures that customers are able to learn and implement successful track and trace efforts. For example, rfxcel educates members on current and potential regulatory requirements, how to on-board new trading partners, and how serialization works.

Full-service approach:

Many small pharmaceutical companies face challenges with DSCSA serialization enforcement including master data management and data exchange with contract manufacturing organizations and wholesalers. rfxcel designates teams across the globe ready to support the entire serialization and track and trace process.

Regardless of size of the company, rfxcel will always find the most cost effective and easy to use solution to comply on time and build business value beyond compliance. When developing the supply chain strategy, rfxcel considers regulations like the DSCSA, and any global differences in associated product descriptions with related literature and support materials.

Awareness and understanding of guidelines and regulations for the serialization of pharmaceuticals products are critical. This awareness includes compliance with regulations (current and planned) that ensure the authenticity, safety, and security of the product.

 

About DSCSA:

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The goal is to  protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain.

 

About rfxcel

Headquartered in the United States, rfxcel is the leading cloud-based provider of serialization, and track and trace solutions. For over fifteen years, rfxcel has provided reliable and affordable solutions to meet global serialization and compliance requirements. With rfxcel’s relentless commitment to customer success and continuous innovation, companies can meet today’s compliance requirements and tomorrow’s business challenges.

rfxcel is the number one managed cloud company for Life Sciences. Everything rfxcel offers is managed by rfxcel not the customers. That’s because rfxcel believes:

  • Commitment to customer success promises a prompt, full-service method of addressing customers’ serialization needs.
  • Economies of scale are nice — but economies of expertise are even more valuable. The highest performance and cost-efficiency come when you combine infrastructure with specialized expertise and the exceptional customer service that we call HyperCare
  • Every customer has easy access to engineers, project managers and experts to help with planning, architecting, building, and operations.

Contact rfxcel for information how to meet your serialization, traceability and compliance requirements. rfxcel is a company committed to innovation and affordability in delivering best-in-class track and trace to Life Sciences across the globe.

 

Countdown to Complying with the Serialization Requirements of the Falsified Medicines Directive

Winning the numbers game: Countdown to complying with the serialisation requirements of the Falsified Medicines Directive

The Falsified Medicines Directive’s (FMD) February 2019 deadline is fast approaching. Those who don’t serialize by this deadline will be unable to sell their products in Europe.

The regulations set forth by the FMD state that every Marketing Authorization Holder (MAH) must upload serialization codes to the European Medicines Verification Organization.

But serialization isn’t a straightforward numbers game, and not all solutions are created equal. rfxcel has provided this document to help you determine how you need to serialize and what you need out of your serialization partner.

Serialization is a daunting, frustrating journey, but having the right solution and the right partner can make a world of difference.

This document aims to help you:

  1. Understand the regulation
  2. Identify the right partner for a serialisation solution
  3. Take these actions

A Quick Guide to The EU Falsified Medicines Directive

A Quick Guide to the EU Falsified Medicines Directive

It’s a time of rapid change for the pharmaceutical industry—new procedures, laws, requirements, strategies, and technologies challenge us to engage with our products in the supply chain like never before. Many of these changes provide new visibility into the pharmaceutical supply chain to help protect patients.

The EU Falsified Medicines Directive (FMD) is one example of these changes. To help accelerate the understanding of this requirement, rfxcel has provided a Quick Guide to EU Falsified Medicines Directive to help you understand:

  1. The Key Requirements of the EU FMD
  2. Complexities Facing the Industry
  3. Preparing to Meet the Deadline

Compliance Checklist – CFR Title 21 Part 11 and EU Annex 11

EU Annex 11 & 21 CFR Part 11 Compliance Checklist

The United States Food and Drug Administration (FDA) and the European Commission have defined regulations for the conditions under which regulated companies can submit electronic records in lieu of paper documents.

These regulations define the measures that must be in place to ensure the integrity, trustworthiness, and reliability of the electronic records.

The regulations define and require three types of controls:

  1. Administrative controls, e.g. the definition of policies such as the identification of individuals and non-repudiation of electronic records.
  2. Procedural controls, e.g. Standard Operating Procedures for using and maintaining the system.
  3. Technical controls e.g. functions built into the software such as security and access to the system as well as the audit trail

For compliance with the regulation, all three of the above controls must be implemented.

Key Industry Terminology

Key Industry Terminology

rfxcel is the leading enterprise software for supply chain and traceability. Major pharmaceutical companies, independent CPOs/CMOs, and wholesalers rely on rfxcel’s expertise in compliance software and support. rfxcel has specialized in core pharmaceutical areas including compliance, tack and trace, serialization and environmental monitoring. Along with a global team and strategic partnership with Verizon, rfxcel has become the #1 independent traceability solution . rfxcel supports its customers in their decision making with rfxcel’s unique 360° approach encompassing capabilities covering global and local markets. rfxcel is committed to its primary mission of supporting customers needs regarding compliance regulations. With absolute visibility into customers’ products, rfxcel is provides value beyond compliance, improving patient safety, customer control and peace of mind.