CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week. The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.” Will it help you?Continue reading Russia: CRPT Posts Test Methodology For Crypto Code
India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption. The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”Continue reading Barcoding Regulation For India’s Domestic Drug Supply
I’m not talking about the mixed signals from Russia in your daily political newsfeed, I’m talking about the mixed signals we see between the Russian Federation decrees for their pharma serialization and traceability mandate, and the announcements of the government’s designated technology contractor to develop that system: CRPT, LLC. Considering how short the deadlines are, these mixed signals are counterproductive because they cause companies to pause while they figure out what they should do. Let me explain.Continue reading Mixed Signals From Russia
At a recent GS1 discussion group meeting one of the moderators acknowledged that they need to create a clear explanation for exactly what EPCIS is. I’ve never been very impressed with GS1’s ability to explain their own standards at a high-level for non-technical readers. They do a great job of explaining them at the minutia-level, but that’s the problem. Non-technical people who must make decisions about GS1 standards probably get bogged down in that minutia and end up not really understanding what it is, why it is significant, and why they should use it. Too much technical documentation exists on how to apply EPCIS, and not enough documentation on the why.Continue reading EPCIS Explained
After November 27, 2017 the U.S. Drug Supply Chain Security Act (DSCSA) requires drug manufacturers (2018 for repackagers) to affix a DSCSA “product identifier” to all drug packages entering the supply chain (see “The DSCSA Product Identifier On Drug Packages”). According to the DSCSA, that product identifier must be present in both human-readable and 2D Data Matrix barcode forms. Part of that product identifier is what is known as a Standardized Numerical Identifier (SNI). The SNI is composed of the drug’s National Drug Code (NDC) and a serial number (see “DSCSA ‘Serial Numbers’”) that is unique on every individual package of that drug (see “FDA Aligns with GS1 SGTIN For SNDC” and “Anatomy Of An FDA SNI”).
Lately, I’ve heard people in the industry claim that it is acceptable to use a GS1 Global Trade Item Number (GTIN) that encapsulates an NDC (see “Depicting An NDC Within A GTIN”) to satisfy the NDC part of this DSCSA requirement to affix the product identifier on a drug package. I’m not so sure about that. Let me explain. Continue reading Is A GS1 GTIN Really Usable As An NDC For DSCSA Compliance? Part 1
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
As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not. That’s probably what the legislatures and regulators who create the requirements think. RxTrace readers know it’s not nearly that easy.
The problem is that every regulation requires something different. The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name). But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same. It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution
Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have been FDA-accredited: HIBCC, ICCBBA and GS1.
ICCBBA has a lock on the identification of Continue reading GS1 Publishes Version 16 Of Their General Specifications …And Why You Should Care