The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”). The MoH is due to publish an assessment of the pilot by next February 1st.
Two weeks ago the Russian Minister of Health, Veroníka Skvortsova, signed the guidelines document for the pilot. The 42-page document appears to be written as a pilot setup document, as opposed to Continue reading The Russia Serialization Pilot Guideline
A “product grouping” is any collection of saleable units of products that are bound together in some way. They can be “bundles”, homogeneous or non-homogeneous cases, totes, pallets or something like these. The pharma serialization regulations in some markets call out some of these groupings for special treatment, and some do not. I’ll try to catalog what we know about product groupings in each of the current, known regulations. Continue reading Serializing Product Groupings Under Global Regulations
Almost 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
Last week I discussed controversy over the use of GS1’s Serial Shipping Container Code (SSCC) in the Brazil pharma supply chain to meet regulatory requirements imposed by ANVISA. But there are different controversies, or at least potential confusion, in the U.S. pharma supply chain surrounding case labels, and some of those are relate to the SSCC and its use.
A case product identification label is the label a manufacturer usually places on each homogeneous case at case-packing time to identify what is inside the corrugated box. A “homogenous case” is a case that Continue reading Identification Of Pharma Cases In The U.S.
GS1’s Serial Shipping Container Code, or SSCC, has been around a long time, but the logistics identifier has recently taken center-stage in a number of controversies related to meeting several country-specific pharma traceability regulations. I’ll cover these controversies in multiple essays—in this one, Brazil.
This controversy started when ANVISA, the pharma regulator in Brazil, indicated in their regulations that they expected companies to mark every “transport package” entering their supply chain with a unique identification code so that each serialized unit inside can be associated with it (the aggregation requirement).
The problem is, a homogeneous case of product can Continue reading ANVISA And The SSCC Controversy
A few weeks ago, GS1 Healthcare US published version 1.1 of their guidance for using the GS1 Electronic Product Code Information Services (EPCIS) standard to meet the U.S. Drug Supply Chain Security Act (DSCSA). See “GS1 Healthcare US Publishes Updated Guidance For DSCSA”. I was too busy at that time to review the document properly, but it is an important addition to the spectrum of information that companies can use to help them understand how to best meet the requirements of the DSCSA so I wanted to get back to it when I had time. That time is now.
As long term readers of RxTrace know, I did not believe EPCIS would ever be usable to meet the now obsolete California Pedigree law (see “The California Pedigree Law Is Now Officially Inoperative”), or any other State pedigree laws, and I do not believe it will be widely used to meet the Federal DSCSA before maybe 2021 or 2022, but I do believe it will take center-stage for meeting the long-term requirements of the DSCSA.
In 2023 the DSCSA transitions into Continue reading The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1