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: pharmaceutical supply chain
Again, A Closer Look At The Six-Year Record-Keeping Requirement
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
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?
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
3PL Operation Under The DSCSA
Another type of business affected by the U.S. Drug Supply Chain Security Act (DSCSA) is the third party logistics provider (3PL) business.
I wrote an RxTrace essay about the impact of the California pedigree law on 3PLs back in 2013 (see “3PL Operation Under California ePedigree“). This is an update of that essay to address the impacts of the new DSCSA on 3PLs since the California pedigree law is now obsolete.
There are a number of important differences between wholesale distributors and 3PLs as defined in the DSCSA. Continue reading 3PL Operation Under The DSCSA
India’s Pharma Export Regulations Update And The NECC Story
I was more than a little disappointed when I saw that SecuringIndustry.com had beaten me in a race to publish an essay/article about the new crazy serialization and traceability requirements published last week by the government of India. That was to be my topic for next Monday. But after reading their excellent coverage—received just as I was sitting down to begin writing—I felt better. At least I had not yet started writing! Don’t miss Phil Taylor’s excellent coverage and his link to the source regulation. See if you agree how crazy it is. The deadlines are now Continue reading India’s Pharma Export Regulations Update And The NECC Story
Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?
The 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?
DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era
There is a not-so-secret situation that has been festering for years in the internal IT systems of many companies in the U.S. pharma supply chain. In the past, nobody liked to admit it, but most would, because the full extent of the problem was hidden away from public view. It was an internal problem mostly affecting only internal systems.
The problem was that the quality of the local master data was poor. Master data is the data that companies hold in internal databases to describe their trading partners (customers and suppliers), products (their own and those of other companies), contract parameters (pricing, authorization, terms and conditions, etc.), and facilities, etc.
Companies get lulled into thinking this data Continue reading DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era
