A serialisation system developed by Systech International has been selected by a ‘top 10’ pharma client as a way of meeting Brazil’s Law 11.903 track and trace requirements.
Systech spokesman Christian Barbato told in-Pharmatechnologist.com that: “While we cannot disclose the name of our customer due to contractual reasons, they are a top 10 global pharmaceutical manufacturer.
He added the customer in question will apply the product tracking system to 18 manufacturing lines at facilities across the country, but again could not go into detail for reasons of client confidentiality.
Barbato also explained that Videojet , Systech’s Brazilian partner, was an important factor in the deal and will be involved in implementation of the Serialized Product Tracking (SPT) at the Pharma client’s plant.
“Videojet is a Value Added Reseller that sells our software and does all of the installation, service and support in the country of Brazil.”
Evolution of Law 11.903
Brazil introduced law 11.903, which requires that the manufacture and distribution of medicine is monitored using electronic data capture technology, in 2009 in a bid to prevent drug counterfeiting, theft and smuggling.
The law, which has been revised several times in the intervening years, requires drugs to be labeled with a 2D data matrix code, a GS1-compliant serial number, a lot number and production and expiry date.
However the multiple changes that have been made to the law have been a challenge for pharmaceutical manufacturers and drug suppliers according to Barbato.
He explained that: “Due to the lack of clarification on the law and companies waiting for clarification, we are only aware of one company that is moving forward [with implementation of track and trace] as of today.”
“However,” he continued “we feel that we are uniquely positioned to satisfy the requirements even as they may still evolve.”