Monday, April 20, 2015

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