Counting Down the Top 10 Articles of 2021 - #1: Serialization 101

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #1, we’re going back to basics with an introductory look at serialization, required by pharma and medical device regulations to defend against counterfeiting.

Jan 4th, 2022

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If you’re following along with our countdown, you may be noticing a trend: traceability content was quite popular with readers this year. In our #1 article, Kim Overstreet provides an overview of of serialization in both the pharma and med device arenas. If you’re looking for more in-depth coverage, check out the following recent articles:

FDA Discusses Nov. 2023 DSCSA Future State

Will Labor Requirements Increase in Meeting DSCSA Milestones?

DSCSA and the Importance of Exception Management

HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization

In the realm of pharmaceuticals, there are some concerning statistics according to the Pharmaceutical Research and Manufacturers of America. One in ten medicines worldwide are presumed to be counterfeit, and 95% of internet drug outlets have been found to be out of compliance with federal and state pharmacy laws & practice standards. During one week alone in March of 2020, over 48,000 packages containing counterfeit medicines were seized by Interpol.

Serialization assigns a unique serial number linked to information about the product origin, batch number, and expiration date, to each saleable unit of each prescription drug product. According to a new report by PMMI Business Intelligence, “Pharmaceutical & Medical Devices | Trends & Opportunities in Packaging Operations,” regulations vary worldwide.

Continue to the full article here: Serialization 101

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2022 Distribution Management Conference (DMC) and Expo in Austin

Hosted by the Healthcare Distribution Alliance, the conference takes place Mar. 6 through 9. This year’s event will feature more than 30 breakout sessions on key distribution issues, including best practices for sending DSCSA-required data.

Serialization Master Data 60a571e0dae99

Counting Down the Top 10 Articles of 2021 - #1: Serialization 101

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #1, we’re going back to basics with an introductory look at serialization, required by pharma and medical device regulations to defend against counterfeiting.

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Counting Down the Top 10 Articles of 2021 - #3: Benefits of RFID on Vial Labels

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #3, we cover ways that RFID benefits health systems, from the perspective of the manager of pharmacy operations at Allegheny Health Network.

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Counting Down the Top 10 Articles of 2021 - #5: Fresenius Kabi Implements RFID

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #5, we cover Fresenius Kabi’s journey to go above and beyond DSCSA requirements, with the support and standards of GS1 US.

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Counting Down the Top 10 Articles of 2021 - #9: Exchanging Pharma Master Data in 2021

Join us as we look back at the most-read Healthcare Packaging stories of 2021. At #9, we cover the exchange master data to meet DSCSA requirements with EPCIS (Electronic Product Code Information Services) files.

FDA Discusses Nov. 2023 DSCSA Future State

At the HDA Traceability Online Seminar (Nov. 1-3, 2021), FDA’s Connie Jung, RPh, talked about how DSCSA continues to transform the pharmaceutical supply chain to preserve drug safety and security.

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Inmar: MEDEX TRAYSAFE MOBILE

A 'lot and expiration-date tracing functionality' enables tracking of distributed inventory and identification of missing, misplaced, expired, and recalled medications.

For product traceability, outbound scanning alone is expected to increase labor by a minimum of 12 to 15% based on recent time studies, per Cardinal Health.

Will Labor Requirements Increase in Meeting DSCSA Milestones?

With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations.

To meet DSCSA requirements, processes must be put into place to handle supply chain data exchange exceptions.

DSCSA and the Importance of Exception Management

At the HDA Traceability Online Seminar (Nov. 1-3, 2021) the topic of handling exceptions ranged from ‘in the weeds’ to the philosophical. Processes are still emerging for data issues, organizing quarantine, and more.

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HDA Foundation Survey Reveals Uneven Progress on Rx Product Serialization

With 2023 DSCSA requirements around the corner, findings reveal aggregation has slowed. Now in its sixth year, this survey, released as part of HDA’s Traceability Online Seminar (November 1–3), assesses industry abilities to meet DSCSA requirements.

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2021 HDA Traceability Online Seminar Takes Place Nov. 1-3

Are you prepared to comply with the DSCSA by 2023? Supply chain stakeholders will convene to discuss the most pressing DSCSA-related topics with experts, including a presentation from FDA.

The Mini Manual Station supports small- and mid-sized aggregation needs.

Mini Manual Aggregation Station for Small- to Mid-Sized Production

Capable of supporting post-lot reworking operations in warehouses and distribution centers, the system is a fit for smaller producers looking to meet upcoming supply chain security requirements.

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Covectra: Enhanced Smart Label and Mobile Authentication

StellaGuard enhancements are designed to allow consumers to more easily and accurately identify, authenticate, and track genuine products and combat counterfeiting using their Android or Apple mobile device.

HDA Survey Offers Some Troubling DSCSA Prep Results

With just two years left to meet the Nov. 2023 DSCSA requirements, a readiness survey shows that there is much work to be done in drug supply chain traceability. 57% of manufacturers surveyed have no successful data connections in production environments.

New Packaging Report Highlights Need for Anti-Counterfeiting

An international trade body comments on a new report that paves the way to ‘significant’ opportunity and growth for packaging holography technologies.

Four DSCSA Guidances Were Released this Summer: Are You Up to Date?

Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.

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Using GS1 Standards to Prepare for DSCSA in 2023

DSCSA requirements to exchange serialized transaction data between trading partners all the way through the supply chain will begin in 2023. GS1 standards allow for universal identification of a product’s history along the supply chain.

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Serialization and Aggregation Systems for Pharmaceuticals

Mettler-Toledo PCE launched the T60 Integrated 360 Series of solutions for serialization and aggregation of bottles and vials in the pharmaceutical sector, enhancing quality control and traceability of products with 360o image capture.

Are You Ready to Exchange Serialization Master Data?

Watch this Take Five video to learn how with limited time left to onboard, experts urge pharmaceutical manufacturers to begin testing and sharing traceability data via EPCIS files with distributors ASAP to meet DSCSA requirements.

Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been mandated to defend against counterfeiting.

Summer Reading Series: Traceability Articles to Catch Up On

Skipping vacation this week? Using your free time to brush up on what you missed? From 'serialization 101' to advice on exchanging master data for DSCSA compliance, here are five articles on healthcare traceability.

More in Traceability/Serialization

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AIM Revises RFID Standard for Healthcare Industry

AIM Standard 7351731 Offers Guidance Evaluating the Immunity of Medical Devices from Exposure to RFID.

Traceability comes with challenges including master data exchange.

Pharma Supply Chain: Master Data Exchange in 2021

The exchange of data needs to move from today’s manual processes to automated operations. Experts recap current progress, challenges, and what a “happy path” looks like.

Micro Marking in Millimeters: Anti-counterfeiting and Brand Protection

HD Barcode and RepExact offer authentication solutions at the Annual US Pharmaceutical Outsourcing & Packaging virtual reality event meant to be efficient, customized, and cost effective.

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Vaccine Visual Inspection and Serialization Combine Integrity and Traceability

The goal is to bring safety and transparency to the vaccine distribution chain and guarantee fairness and correctness. Emidio Zorzella, President and CEO of the Group: 'The pandemic has accelerated the adoption of new technologies'.

A new offering in the connected packaging space—RFID-embedded vial labels that manufacturers can implement without artwork changes.

Perspective: Inventory Management in the Hot Seat

RFID labels are changing the way hospitals track and dispense drugs—will the benefits cause a demand surge for connected packaging? In other sectors, tracking inventory is key to preventing production bottlenecks.

Molecular tagging and blockchain keep cannabis safe across the supply chain.

Securing Cannabis Across the Supply Chain

Applied DNA Sciences and and TruTrace Technologies team up to tag, test, and track cannabis products from seed to sale.

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HDA’s Traceability Webinar Series Explores the Path to 2023

The series takes place on April 15, April 29, May 12, and May 19, and covers DSCSA basics, data exchange, practical approaches for health system pharmacies, and more.

Part 2: RFID Labels Open Doors for Continuous Supply Chain Improvement

In this Q&A, a manager of pharmacy operations explains why RFID-embedded vial labels just may change the world of inventory management and dispensing.

With the CCL/Kit Check partnership, manufacturers receive labels with RFID inlay that appear identical to their existing label—and don’t require artwork changes and new FDA approval—and do not affect packaging lines.

Part 1: From Drug Supply to Staffing, the Benefits of RFID Integrated into Vial Labels

In this Q&A, a manager of pharmacy operations explains why RFID-embedded vial labels just may change the world of inventory management and dispensing.

Sovereign Pharmaceuticals Becomes First Manufacturer to Earn All GS1 EPCIS Trustmarks for FDA DSCSA Interoperability Mandate

Drummond Group & Vantage Consulting Key Partners in Sovereign’s Implementation of Drummond Certified™ QU4RTET Track and Trace Solution

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Covectra: Smart Label and Mobile Authentication

Next Generation Stellaguard brings mobile product authentication to consumers worldwide; combines two methods of simultaneous authentication with serialization and random patterns and numbers of holographic stars.

With MEMS AS®-Platform from AARDEX, the data from the dosing history of the smart packaging from Schreiner MediPharm are visualized and analyzed.

Schreiner MediPharm and AARDEX: Smart Digital Therapy Management Solution for Clinical Trials

Smart Blister Packs and Smart Kit Boxes link medicine packaging with matching software for enhanced trial participant monitoring capabilities.