Showing posts with label GS1. Show all posts
Showing posts with label GS1. Show all posts

Tuesday, September 10, 2019

GS1 Lightweight Messaging Standard

Open the full guideline document:   GS1 Healthcare US - Implementation Guideline - Applying the GS1 Lightweight Messaging Standard for DSCSA Verification of Returned Product Identifiers (PDF)

According to the guideline document:

"In preparation, pharmaceutical supply chain stakeholders collaborated with GS1® and GS1 US® to develop a verification messaging standard to enable system interoperability and prevent the proliferation of multiple messaging formats. In addition, the GS1 Messaging Standard Workgroup collaborated with the Healthcare Distribution Alliance (HDA) Verification Routing Services (VRS) Taskforce. These efforts produced the GS1 Lightweight Messaging Standard for Verification of Product Identifiers.

The GS1 Lightweight Messaging Standard was designed to support requests and responses for verification of product identifiers for serialized pharmaceutical products. It is intended to provide a simple, standardized lightweight messaging framework for asking verification questions and receiving actionable information. Designed to support Verification Routing Services (VRS) systems for DSCSA verification, the messaging standard defines a verification request message and a corresponding response message."

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The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.
The largest selection of Board-approved California Designated Representative online training programs. 3 distinct courses for wholesalers, 3PL, reverse distributors. Earns a training affidavit.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Friday, March 8, 2019

Real World Product Serialization: Report from the Warehouse - LSPedia

Updated April 23, 2024

The original link broke.

You might also be interested in:  LSPedia

---  the original post follows below  ---

Read the full article:  Real World Product Serialization: Report from the Warehouse - LSPedia

"Even though manufacturers have invested lots of time and money into DSCSA serialization compliance, the LSPediA team found that many products still won’t scan up to standards."

The article points out that serialization efforts are making slow progress, and implemented barcodes can contain errors or fail scans.

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - for wholesalers


Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Wednesday, November 23, 2016

Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS

Read the full article: Companies Collaborate on DSCSA Guideline as Deadlines Approach | RAPS:

"GS1 Guideline

The 600+ page GS1 guideline and compendia offer information and examples to the wider industry looking to meet the law's obligations and record each shipping event and data element needed to support serialization, pedigree and track and trace. The guideline also shows industry how to apply the standards to their own businesses."

'via Blog this'

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Training for Designated Representative and Designated Representative-3PL license applicants


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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

Thursday, November 6, 2014

FDA blows off GS1 Healthcare for facility identification schema

Read the full article: FDA blows off GS1 Healthcare for facility identification schema - Pharmaceutical Commerce:

"What’s left unsaid in the document is how establishment location data necessary for tracking drug shipments (as opposed to filing paperwork with FDA) will be reconciled with DUNS. GS1’s interlocking numbering systems—GTIN for product identification, GLN for physical locations, and the EPCIS system for communicating transaction information (among others)—is looked on as the likely choice for structuring drug traceability under the Drug Supply Chain Security Act (DSCSA); additionally, many of the leading group purchasing organizations (GPOs) have been pushing suppliers (including pharma companies) to use GS1’s GLN and GTIN format for recording shipments to member organizations. GLN has the advantage over DUNS (which originated as a way to track the financial records of companies) of providing a high degree of precision on location—the specific loading dock at a hospital pharmacy, for example."

'via Blog this'

Read the document:
FDA Guidance - Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (PDF)

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


Thursday, September 18, 2014

Free Download - Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA - GS1 US

Updated June 1, 2025

The original link got outdated and broke.

You might also be interested in:

GS1 US DSCSA Implementation Suite


-----  original post follows below  ------

Request to download the free guide: Implementation Guideline - Applying GS1 Standards to US Pharma Supply Chain Business Processes to support DSCSA - GS1 US:

"This guideline offers pharmaceutical industry stakeholders best practices for meeting immediate lot-level management deadlines, and sets the foundation for serialized item-level traceability. Release 1.1 of the GS1 Healthcare US Implementation Guideline, “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to support DSCSA”, will help companies comply with early term, mid term and later requirements defined in the 2013 DSCSA law."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, third-party logistics provider, 3PL) - Approved by the California State Board of Pharmacy - Earns a training affidavit

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):
     Florida:

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):


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