ICYMI: FDA Released Three DSCSA-Related Guidances

New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.

Oct 4th, 2018

New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.

New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.

The following is a list of recent guidance documents released or finalized by the FDA. For more analysis of these documents, check out Dirk Rogers’ column: FDA’s Late Recommendation on Human-Readable Format

1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry

This 14-page draft guidance is intended to address anticipated questions regarding product identifiers that are required under section 582 of the Federal Food, Drug, and Cosmetic Act as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products.

Manufacturers and repackagers must affix or imprint a product identifier to each package and homogenous case on Nov. 27, 2017 and Nov. 28, 2018, respectively.

2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

This 9-page guidance addresses product distribution security provisions in section 582 of the Federal Food, Drug, and Cosmetic Act.

3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy

This 4-page guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that manufacturers affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning not later than November 27, 2017. It also points to the finalized grandfathering guidance.

Sovereign implemented serialization and aggregation on all three configurations of packaging lines at once.

CDMO Speeds its Line with Open-Source L4 Serialization System

With the serialization deadline approaching, Sovereign Pharmaceuticals implemented open-source software that allows the company to make their own changes and improve packaging efficiency.

This software release is a direct response to customer feedback on ways to improve Cr&emacr;do ProEnvision.

Pelican BioThermal: Updated Asset Management Software

Version designed to advance smart management of temperature-controlled shipments and set the foundation for future IoT integration.

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Dover to Acquire Systech International, a Leading Provider of Serialization, Traceability and Anti-Counterfeiting Solutions

Enhances Dover's Product Identification and Traceability Solutions Portfolio

By scanning a QR code on the bottom of the Friso infant formula packaging, consumers can learn about the product's journey from the farm to their home.

Live from AIPIA: QR Code Accesses Baby Formula’s ‘Grass-to-Glass’ Journey

Pharma Counterfeit Drug Market Growing by 20% Per Year

$200 Billion Pharma Counterfeit Drug Market Growing by 20% Per Year

This alarming growth is twice the rate of the legitimate pharmaceutical market, and accounts for 2.5% of the total global pharma market.

45% of global consumers use a smart device to monitor a health condition.

Will Smart Technology Help Seniors with Pharma and Healthcare Compliance?

RFID, NFC, Bluetooth, and QR enabled packaging are on the forefront of technology solutions in the healthcare industry for pharmaceutical and medical device packaging, with 45% of global consumers using a smart device to monitor a health condition.

Emilie Peltre, Senior Principal Packaging Engineer for Abbott opens the Abbott Connected Health Challenge at the AIPIA World Congress.

Live from AIPIA: Abbott Connected Health Challenge

Thirteen smart packaging technology providers pitch their solutions to Abbott to help them create connected packaging that links its consumers to services.

Holographic foils can be used to great effect to differentiate product at the point-of-sale.

Using Holography to Fight Pharmaceutical and Healthcare Brand Piracy

Column: New trends in pharma packaging follow developments in emerging markets, demographic changes and new technologies that include holography, says chairman of the International Hologram Manufacturers Association.

Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain

TraceLink: Digital Network Platform to Further Transform the Global Pharmaceutical Supply Chain

The platform is designed to allow users to rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration across the end-to-end life sciences value chain.

Zantac and generic versions of the popular heartburn medicine face concerns about contaminants.

How QR Codes Can Help Drug Makers Streamline Recalls

Concerns about a carcinogenic impurity have prompted recalls of Zantac and generic versions of the popular heartburn medication. Smart labeling technology could speed and clarify alerts to consumers and also help drug companies reduce scrapped lots.

Saleable Returns Enforcement Delayed to 2020

Saleable Returns Enforcement Delayed to 2020

FDA final guidance says distributors will not be required to verify the product identifier of returned drugs before resale until 27 November 2020.

DSCSA: Where Are We, and Where Are We Going?

DSCSA: Where Are We, and Where Are We Going?

Recapping current progress, the Nov. 2019 saleable returns deadline and the supply chain transformation expected in 2023.

Grass-to-Glass Traceability and Consumer Engagement for Infant Formula Brand, Friso

Kezzler enables FrieslandCampina to reinforce transparency and build trust with Chinese consumers.

Company Reports Three out of Ten 2D Barcodes Failing, Letter Stresses Saleable Returns Challenges

Company Reports Three out of Ten 2D Barcodes Failing, Letter Stresses Saleable Returns Challenges

Returns verification requirement deadline is approaching fast.

Antares Vision's TrackMyWay Traceability System

Antares Vision: Traceability System with Consumer Engagement Capabilities

TrackMyWay platform offers supply chain transparency through stakeholder communication, and customer engagement.

The user-friendly Antares system helps PCI save time.

Aggregation Proves Beneficial in a Contract (and Compact) Pharma Facility

Implementing new equipment where space is at a premium, PCI was able to incorporate aggregation and decrease inconsistencies in reconciliation.

he Robocombi system mechanically picks the strips of bottlepacks from the conveyors they stand in and places them directly into the four parallel conveyor lanes leading to the packaging line.

Sanofi Oral Suspension: From Blow/Fill/Seal to Robotic Palletizing

At Sanofi’s Origgio facility outside Milan, automated efficiency is the watchword when it comes to packaging Enterogermina Oral Suspension. Additional production capacity is in the works.

Pfizer's Viagra and Kezzler's Serialization Technology

Pfizer Combats Counterfeited Viagra in Hong Kong

Through serialization technology, pharmaceutical company Pfizer was able to target the distribution of counterfeit Viagra in Hong Kong.

One of ACG Inspection's (ACGI) signature services, VeriShield

ACG Inspection Installs 1,000th Track & Trace Line

ACG’s comprehensive serialization services implemented in more than 100 countries around the world.

Naseem Amin, CEO at GMP-Orphan (PC: GMP-Orphan)

Q&A: The Impact and Benefit of Serialization on Rare Disease Therapies

At FutureLink Barcelona 2019 in June, the serialization discussion will focus on the value of digital information sharing Can healthcare manufacturers use data to help patients and physicians?

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Central Pharma selected the Veratrak platform to help achieve digitized end-to-end visibility of the supply chain and improve collaboration.

Contract Packaging Organization Digitizes Supply Chain Operations

Central Pharma selected the Veratrak platform to help achieve digitized end-to-end visibility of the supply chain and improve collaboration.

AVionics is designed to utilize data collected for serialization compliance to help improve production practices.

Antares Vision: Line Efficiency Monitoring System

AVionics is designed to utilize data collected for serialization compliance to help improve production practices. The system monitors real-time production status, instant and accumulated speed, overall equipment efficiency and camera performance.

TQS serial numbering system with classical mechanical position indicators from SIKO (Image: © WIPOTEC-OCS)

Electronic Position Indicators Ensure Process Security in Track-and-Trace Systems

Compliance with the EU FMD requires implementation of traceability systems. The TQS (Traceable Quality System) from WIPOTEC-OCS employs a position indicator from SIKO GmbH that offers process security during format changes.

Part Three of a Special Report illustrates the range of package formats involved in corporate serialization efforts.

Cartons and Bottles Most Serialized Package Types

Part Three of a Special Report illustrates the range of package formats involved in corporate serialization efforts.

AVrs from Antares Vision

Antares Vision: Verification Router Service System for DSCSA Compliance

AVrs is designed to offer efficient data management and compatibility with external software and hardware.

TEKLYNX vial scanner

TEKLYNX: Enterprise Labeling

TEKLYNX CENTRAL CFR 5.0 and TEKLYNX CENTRAL GHS 5.0 offer companies in medical device, pharmaceutical, life sciences and chemical manufacturing a centralized system for label design, security and traceability, print automation and regulatory compliance.

While pharmaceutical companies likely won’t see large returns on their investment, they have a unique opportunity to start monitoring metrics such as OEE, product loss, and dwell time

Live from Interphex: The Human Challenge in Manual Aggregation

Six months after the serialization enforcement date, a new challenge emerges. Staff and processes must be set up to keep rejected product… rejected.

Radio-Frequency Identification (RFID) tags are embedded on all prefilled syringe products at the Nephron 503B Outsourcing Facility.

Nephron Pharmaceuticals Implements Kit Check for Serialization of Prefilled Syringes

Radio-Frequency Identification (RFID) tags are embedded on all prefilled syringe products at the Nephron 503B Outsourcing Facility.

Manufacturers that receive a verification request from a wholesaler/distributor or dispenser will be required to verify all serialized packages.

DSCSA Focus Shifts to Wholesaler/Distributors

Healthcare Packaging looks at the Drug Supply Chain Security Act (DSCSA), circa 2019, in this exclusive interview with Peter Sturtevant, Senior Director, Industry Engagement—Pharmaceuticals, GS1 US.

Kezzler Announces Six Billion Products with Unique Digital Identities in 2019

Kezzler Announces Six Billion Products with Unique Digital Identities in 2019

Kezzler’s campaign records half a million consumer interactions daily, peaking above 1,800 API calls per minute.

Part Two of a Special Report on serialization demonstrates the wide range of job duties tasked with the responsibility of meeting this mandate.

Serialization Responsibilities Spread Across a Diversity of Job Functions

Part Two of a Special Report on serialization demonstrates the wide range of job duties tasked with the responsibility of meeting this mandate.

Part One of a Special Report on serialization shows how companies delegated responsibilities within their internal departments to meet serialization mandates.

Serialization Leadership Reflects Corporate Culture

Part One of a Special Report on serialization shows how companies delegated responsibilities within their internal departments to meet serialization mandates.