Last 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
Tag Archives: serialization
Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners?
I spent my holiday weekend having fun with my family and I hope you did the same. Instead of spending my holiday writing a new RxTrace essay I am re-running one of my better essays, originally posted on October 6, 2014. If you missed it then, or even if you read it then, it is worth another read. See if you agree:
Manufacturers who make use of third-party contract manufacturers, contract packagers and/or third-party logistics providers (3PLs) may wish to off-load their 2015 and 2017 obligations under the U.S. Drug Supply Chain Security Act (DSCSA) to those contract organizations. These obligations include Continue reading Again, Should You Off-Load Your DSCSA Obligations To Your Contract Partners?
An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?
Dear FDA, EMA and ANVISA,
How are you? I’m sure your summer has been busy, just like mine. Hope you were able to get at least some time away. I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday. You know, the wife is not very happy about that!
The reason I am writing directly to you at this time is to ask a question that I hope you are asking yourselves and planning ahead for. Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?
Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015
It’s August and that means it is time to check in on the progress toward full serialization of drugs in the U.S. supply chain. This is an annual look I’ve been doing for five years now. For my previous essays, see:
- “Estimated Rise In Serialized Drugs In The U.S. Supply Chain”;
- “Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2011“;
- “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2012“;
- “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2013“;
- “InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014”.
In each essay I produced a graph of my own personal estimate Continue reading Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2015
Your Plain Old Package: Unlock Its Built-in Brand Protection Capability
When serialization of drugs was first being considered for pharmaceuticals back in the mid-2000s, I recall that it seemed to rattle the traditional brand protection vendors who offered package-level authentication technologies. They were more than a little worried that drug companies would end up using serial numbers in place of their more traditional offerings, like holograms, specialty inks, micro-printing and other technologies. Back then, some drug companies were looking at using Radio Frequency IDentification (RFID) tags to carry the serial numbers on their drug packaging, and perhaps these vendors feared that they would be left out.
I never understood what all the angst was about. Continue reading Your Plain Old Package: Unlock Its Built-in Brand Protection Capability
India Proposes Serialization of Domestic Drug Supply
Last month India’s Central Government published a proposal for comment that, if enacted, would cause all drugs entering the Indian domestic supply to contain unique serial numbers encoded within 2D barcodes, and including aggregation and data reporting–all 180 days after publication of the final rule.
If you download the PDF, don’t be disappointed when you find that the first couple of pages are in Hindi. The full text is also included in English, starting on page 3.
RxTrace readers will recall that India Continue reading India Proposes Serialization of Domestic Drug Supply
InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA
The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers). These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).
A common question is, what is the smallest level of packaging that must be serialized?. The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA
ANVISA And The SSCC Controversy
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
