ACG Inspection (ACGI), a business unit of ACG Group that provides manufacturing solutions for the pharmaceutical industry, recently completed the supply, installation and validation of its 1,000th Track & Trace line.
ACGI offers two track and trace services. VeriShield, which includes serialization and aggregation of cartons and bottles at the primary, secondary and tertiary packaging levels and QualiShield, which is a complementary range of camera inspection solutions for pharma doses, labels, and cartons.
The company’s CEO, Ettore Cucchetti, spoke to in-PharmaTechnologist about the challenges companies are facing in order to comply with the recent European Union’s Falsified Medicines Directive (FMD), which was introduced to fight drug counterfeiting.
According to Cucchetti, adopting the EU FMD will result in an overhaul of all manufacturing processes for pharmaceutical companies, including their contract manufacturing and packaging partners.
Implementing serialization requires a thorough understanding of the regulations, selecting the right machinery and changes in the line layouts, Cucchetti told us.
In addition, the companies will need to manage and exchange the highly complex set of product information and serialization data with their entire supply chain, including wholesalers, brokers and retailers.
As the EU FMD also necessitates the demand for verification of the serialized product identifier at least once before the product is dispensed to the patient, data management throughout the supply chain is critical, according to Cucchetti.
Changing the packaging line also has an adverse effect on overall productivity. “Evidence from early adopters of serialization has demonstrated that productivity, in terms of overall equipment effectiveness, can decrease by as much as 10%,” Cucchetti outlined.
Pharmaceutical companies in the EU are also concerned about the cost implications associated with the upgrading of pharmaceutical packaging lines to apply serialization and tamper verification features.
Cucchetti said, “Generic manufacturers employ thousands of’ packaging lines, and the upgrading of these lines to implement serialization and tamper verification features costs about €500.000 ($561,962) per packaging line.”
“The directives also mandate that the repository systems be paid for by medicine manufacturers, adding a further cost of around €100m per year. Thus highlighting the huge costs associated with EU FMD implementation, which are over and above the existing costs of current regulatory requirements” he added.
