Inkjet & Digital Printing
Control Pharma Unveils Centre of Excellence for E-Pedigree Compliance
Tuesday 22. July 2008 - Impending legislation relating to mass serialisation of pharmaceutical products is one of the biggest challenges facing the sector right now, with a number of countries about to mandate serialisation and traceability regimes as a means of combatting counterfeit products, ensuring patient safety and eliminating reimbursement fraud.
Implementing this solution across all pharmaceutical lines on a global basis is a massive undertaking for the industry and its suppliers. It requires a robust software solution and significant integration with the many different types of hardware found on existing pharmaceutical lines. All of this needs to be compliant and validated to pharmaceutical standards and available on a global basis.
One of the most stringent of these mass serialisation or electronic pedigree schemes will shortly be implemented by California Board of Pharmacy in the USA and will apply to all prescription drugs dispensed in the state, irrespective of where they are manufactured. With a short compliance timescale relative to the typical capex cycle of ethical pharmaceutical manufacturers, the pharma sector is actively seeking and evaluating serialisation solutions.
The 2007 acquisition of Control (Koblenz, Germany) means that Domino is uniquely placed to deliver mass serialisation of products: Control offers a fully functioning, integrated production line management package currently in operation on over 70 pharmaceutical production lines. The software is JAVA based and can be configured on all major operating platforms, incorporates drivers for over 70 variations of equipment and is compliant with ISO 9001:2000 and pharmaceutical GMP and validation procedures.
The combination of Controls powerful software with Dominos expertise in all coding & marking technologies and systems integration capabilities is the perfect platform from which to provide validated (ISO, GAMP, FDA – 21 CFR Part11) track & trace solutions. As a result, Domino is already in a position to demonstrate proven e-pedigree compliance solutions that adapt to and add value to everyday manufacturing and packaging operations in the pharmaceutical sector. Flexible and cost-effective to deploy, the package complies with every known and anticipated e-pedigree legislation.
In order to prove the capability of the Control software and to demonstrate the challenges of integrating the solution onto an existing line, Control has implemented its solution on a live production line at the MeditraQ Centre of Excellence near Amsterdam, in the Netherlands. This is a unique demonstration showing the full solution from blister level to pallet – the first in the world. Control has clearly shown that it can offer solutions and enhancements to these solutions that meet customer requirements as legislative dates near.
The global sales effort for Control Pharma is being headed up by John Pitts, previously Pharma Business Development Manager at Domino Amjet, Inc. (Gurnee, Illinois). “Supply chain traceability is an increasingly significant issue across almost every sector for a variety of reasons,” says Pitts. “Retailers can benefit from improved ordering procedures and stock rotation; for manufacturers of high-value or high-risk products its a valuable weapon against the growing trade in counterfeit drugs and ultimately it provides protection for the consumer by ensuring they receive a genuine product. The compliance-driven pharmaceutical sector is at the forefront of this programme due to the nature of its product, which is why we believe it appropriate to establish a highly-specialised team to focus on pharma sector requirements.”