Why serialization is vital for pharmaceutical product integrity in the cold chain

Read entire article at the Cold Chain View blog.

More than ever before, drug security is an important issue in ensuring the integrity of medicines and vaccines reaching patients. The industry needs to demonstrate that we care for patients, and are putting all necessary measures in place to ensure that medicines are safe to be taken.

That means knowing the entire journey of a medicine through the supply chain, and having fully automated documentation about the conditions on its journey. One of the ways in which this can be addressed in the cold supply chain is through serialization. A key driver for implementing serialization will be global compliance requirements coming into play. The USA introduced the Drug Supply Chain Security Act at the end of 2013, which will require the availability of information at individual package level about where a drug has been in the supply chain.

Making the business case for implementing serialization cost-effectively in the supply chain

Read the full article at the Cold Chain View blog.

As part of the implementation of serialization, automation of the process will become law within 10 years. As already highlighted previously, serialization provides accountability and traceability of every item shipped in the supply chain. The need to conform to these new requirements might at first glance look like it would require costly additional investment. But it need not be – and it might even be more cost-effective, once you take into account the additional benefits that could be obtained.

Frequentz Inc's Track and Trace Solution news

PALO ALTO, Calif., April 28, 2015 - As the counterfeit drug market grows and the pharmaceutical supply chain becomes more complex, Frequentz Inc., a global leader and champion of end-to-end visibility, is proud to announce they are validating medications flowing through two-thirds of the 67,000 U.S. pharmacies. Frequentz's track and trace system is utilized by two of the top three global distributors of pharmaceuticals, increasing Frequentz's ability to help keep consumers safe. With such broad reach, Frequentz gives consumers the confidence they can trust the medications coming from the majority of pharmacies and contract manufacturers.

Read full article at PR Newswire

ANVISA And The SSCC Controversy - By Dirk Rodgers

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 be both a “standard grouping” of the product and a transport package. GS1 recommends that “standard groupings” of product be marked with its own GS1 Global Trade Item Number, or GTIN. Read the full article at RxTrace.com - Author Dirk Rodgers

India’s Pharma Export Regulations Update And The NECC Story

India’s Pharma Export Regulations Update And The NECC Story - By Dirk Rodgers of RxTrace.com
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. View full article here

2-D or RFID: Which is better for item-level marking?

Saat ini barcode sudah tidak asing lagi karena banyak company telah mengimplementasikan dengan berbagai tujuan dan kebutuhan terutama disisi kebutuhan tracebility. Sedemikian jamaknya teknologi ini mendorong vendor barcode menyediakan beragam tipe dan tingkatan teknologi termasuk RFID bahkan saat ini telah berkembang teknology visual barcode. Dilain waktu saya akan posting subject visual barcode. Pada artikel dibawah […]


https://logisticexpert.wordpress.com/2015/02/20/2-d-or-rfid-which-is-better-for-item-level-marking/

Progress Toward Serialization!

"Frequentz has published the 2015 RxTrace U.S. Pharma Traceability Survey Results and Dirk Rodgers, of rxtrace.com, reviews some interesting findings taken directly from the report. Dirk talks about how the report shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market. That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013." Read Dirk's full blog at Progress Toward Serialization!?.