Tag Archives: EPCIS

GLN

GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance

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iStock_000085320577_SmallerAlmost everyone agrees that GS1’s Electronic Product Code Information Services (EPCIS) standard will be used by drug manufacturers and the large wholesale distributors in the United States for compliance with the serialization requirement of the Drug Supply Chain Security Act (DSCSA).  Even I think that (see “Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?”).  But there is a problem that could kill its use beyond the internal uses of today, keeping it from being used for data exchange or the data repositories that will eventually become the way data is “exchanged” in 2023 as part of the Enhanced Drug Distribution Security (EDDS) phase of the DSCSA.

The problem is, EPCIS defaults to the use of a single location identifier, the GS1 Global Location Number (GLN).  So what?  Why is that a problem?  Let me explain. Continue reading GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance →

FDA Workshop

The 2016 FDA Pilots Workshop

2016-04-05 14.11.09.reducedI was initially disappointed in the FDA Drug Supply Chain Security Act (DSCSA) Pilots Workshop that was held at FDA headquarters last week, but in the end, the outcome appeared to fit the need.  Going in, I knew not to expect the FDA to convey any information to the attendees, so that is not why I was disappointed.  I attended the public DSCSA workshop they held back in May of 2014 so I already knew their typical approach for workshops like these (see “The 2014 FDA DSCSA Workshop”).  I knew that the purpose of the workshop was to inform the FDA, not to inform the attendees.  I would estimate that about one out of every four attendees were expecting the opposite, and I would bet a significant percentage of those had not even read the DSCSA once.  But that’s not why I was disappointed.

I was initially disappointed because Continue reading The 2016 FDA Pilots Workshop →

ANVISA

The Official Suspension of the Three-Lot Pilot in Brazil

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395px-Coat_of_arms_of_Brazil.svgOn October 23, 2015, a very brief resolution was published in the Official Diary of the Union (Diário Oficial da União) (Brazil’s equivalent to the U.S. Federal Register) which formally suspends the 3-lot track and trace pilot that drug registration-holders were formerly required to complete by December 10 of this year (see “Brazil Suspends Pharma Serialization And Tracing Requirements”).  Apparently, that makes it official.  The new resolution is numbered RDC-45 and it is dated October 22, 2015.  Of course, this new resolution is only available officially in Portuguese, but here is an unofficial translation of its core contents in English: Continue reading The Official Suspension of the Three-Lot Pilot in Brazil →

SAP

SAP Makes Bold Move Into Pharma Traceability

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sap-erp-graphicLast week SAP announced the availability of their brand new software module they are calling “SAP Advanced Track and Trace for Pharmaceuticals”, or ATTP.  Pharmaceutical Commerce magazine published an article about it recently that provides the details of what is contained in this new module.  The same issue contained a sponsored article from SAP about the module.  As long-term readers of RxTrace know, I do not endorse specific products and I rarely even write about specific products.  This essay is not an endorsement— Continue reading SAP Makes Bold Move Into Pharma Traceability →

Record-keeping

Again, A Closer Look At The Six-Year Record-Keeping Requirement

I sat on my back porch gazing at this amazing sky all afternoon Sunday.
I sat on my back porch gazing at this amazing sky all afternoon Sunday.

It was a very beautiful weekend here in the Chicago area, and consequently I could not bring myself to spend any part of it sitting in front of a computer hammering out a new essay, so for the second week in a row (sorry), here is a re-run of a popular essay from July 14, 2014.  I promise to return next week with a brand new essay.

??????????The Drug Supply Chain Security Act (DSCSA) contains record-keeping requirements for drug manufacturers, wholesale distributors, repackagers and dispensers that begin on January 1st, 2015,  All companies must keep a copy of the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) they receive and those they send for at least six years.  In addition, manufacturers and repackagers must also retain Continue reading Again, A Closer Look At The Six-Year Record-Keeping Requirement →

Data Exchange

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

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SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday? →

Rx-360, Traceability models

InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper

rx-360-logoLast week, Rx-360, a pharma supply chain consortium aimed at patient safety through a secure supply chain, quietly published the white paper on Traceability Data Exchange Architecture (TDEA) (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”).

This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document.  In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if Continue reading InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper →

Thank You!

Thank You Bob Celeste!

Bob Celeste
Bob Celeste of RCPartners

I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US.  Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others.  Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.

Bob started working for GS1 back when Continue reading Thank You Bob Celeste! →