To meet Brazil's anti-counterfeiting regulatory requirements
A leading pharmaceutical manufacturer is to install Systech's Serialised Product Tracking (SPT) solution on each of its packaging lines in Brazil. The manufacturer will employ Systech SPT to meet Brazil's pending anti-counterfeiting track and trace requirement and work with Videojet, Systech’s Brazilian partner.
‘Pharmaceutical counterfeiting is a global problem that is growing rapidly,’ said Joe Ringwood, COO at Cranbury, NJ, US-based Systech International.
‘In response, more countries like Brazil are legislating regulatory requirements that require item, case and pallet level serialisation. We're thrilled to help this top manufacturer efficiently address Brazil's pending legislation and guard its supply chain from dangerous, illegitimate products.’
Brazil's Law 11.903, passed in 2009, requires the ‘tracking of manufacturing and consumption of medicine by means of data capturing, storing, and electronic transmission technology’.
To address this mandate, the pharma manufacturer required an end-to-end solution capable of item-level serialisation; aggregation of items into cases and cases into pallets; and inspection of tamper-evident labelling over carton end flaps plus a security label to be distributed by ANVISA.
The company also needed centralised palletising; post-lot re-work; full integration into SAP Aii; and flexibility to accommodate any current or future regulations
Systech SPT allocates and verifies unique identification numbers at the item level. If aggregation of serialisation data is required, such as in Brazil, the item (child) is then packaged into a higher level carton (the parent), thereby establishing relevant parent-child relationship between item, case, and pallet.
The solution also maintains data integrity throughout the entire packaging process, thus ensuring that the manufacturer's serialisation and aggregation data are accurate. This enables the manufacturer to track products and verify their legitimacy across the supply chain, while meeting regulatory requirements.
Systech says its partnership with Videojet Brazil was a key factor in the pharma manufacturer's decision to employ SPT. Coding and marking specialist Videojet sells, installs, and supports Systech's SPT solution in Brazil. The company has expertise deploying its coding and marking solutions on pharmaceutical packaging lines throughout Brazil as well as complex hardware and software integrations.
‘We're pleased that this manufacturer sees the strategic value in SPT and the partnership between Systech and Videojet,’ said Andre Santos, Country Manager, Videojet Brazil. ‘Our training and in-region support will significantly help this manufacturer successfully implement SPT and meet Brazil's regulatory requirements.’