News-Medical speaks to Sue Miles from PCI about the dangers of counterfeit pharmaceutical products and how the serialization services offered by PCI are reducing the risk of products being altered during transit.
Please can you give a brief introduction to serialization?
Pharmaceutical Serialization is a process whereby every saleable pack of drug product will have a unique Serial Code related to its Global Trade Identification Number (GTIN). The packaging of drugs will need to change to enable the inclusion of (typically) a 2D Matrix barcode and 4 elements of human readable text in replacement of the current Lot & Expiry. Although these two codes are still present, they are most commonly joined by the product GTIN and its serial number.
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There are a number of different regulations in force today, and several more in the pipeline. Some simply require a special code to be added, others go as far as creating a framework for total Supply Chain traceability, such as California’s ePedigree requirements (although this may be overturned by the US Government in the next few months).
Manufacturers are required to retain details of ‘active’ serial numbers and be capable of responding to a request for an authenticity check from a distributor or pharmacy.
How much of a problem is global counterfeiting in the Pharmaceutical industry?
Counterfeiting costs the Pharmaceutical Manufacturers many Billions of $ per annum. More importantly though, it costs many 1000’s of people their lives because the drugs they are taking in good faith do not contain the correct active product or, in some cases, no active product at all. This is, without doubt, a massive human issue on a global scale.
What anticounterfeiting technology solutions are currently available? How well do you think these work?
Today, there are many ways companies have tried to reduce counterfeiting using a variety of methods, from the addition of Tamper Seals, at the simplest end, right through to the inclusion of Micro Text or holograms within the artwork. Some companies are already serializing product, but purely for their own purposes.
Please can you outline PCI’s services and how they help overcome counterfeiting in the Pharmaceutical industry?
PCI is building capability to comply with all global Serialization standards. We have chosen a global partner for this, Antares Vision, and using their hardware & software, we can comply with all current regulations for generation and application of Serialization and Track & Trace. We are also capable to work with our customers to help design complex packaging and coding/security elements which can reduce the risk of counterfeiting.
How do PCI’s services compare to those of their competitors?
As the largest Global Footprint contract pharmaceutical packager, we have certainly chosen a world leading partner to create our serialization offering. We believe that we can offer highly flexible solutions across our network of Sites in UK (4) & USA (7) to give our clients an unrivalled choice of where to package their products where it makes sense to them and also to reduce the Supply Chain miles and hence carbon footprint.
How difficult is it for companies to stay on top of serialization regulations?
Suffice to say, there are many different regs and new ones in the pipeline. It is important that a company gets the right partners to help in this process. The Serialization software providers need to stay on top of the changes (for example the recent announcement that China is to create its own version of the 2D matrix and not use the GS1 standard.
Do you think anticounterfeiting initiatives are likely to grow in importance going forwards?
Yes, there are plenty of regions that have not decided which way to go with Serialization and other measures to combat anti-counterfeiting. This will be an ongoing ‘game’, similar to that undergone by the banks a few years ago with Pins, then Chips, then contactless etc.
What are PCI’s plans for the future?
PCI is working with all clients who produce product that requires serialization to develop solutions to meet their specific requirements; we are also investing heavily in packaging technologies and techniques. We believe that this combined with the global serialization effort will help our clients beat the counterfeiters and thus ensure we all minimize the impact of the grey market on public health.
Where can readers find more information?
PCI Pharmaceutical Services
About Dr. Sue Miles
With a career in the clinical trials services industry spanning 16 years, Sue’s experience in clinical programmes encompasses each step of the product lifecycle from development to commercialization.
After gaining a degree in Natural Sciences from Cambridge University and a Ph.D. in reproductive biology from The University of Edinburgh, Sue spent three years in an R&D research role before making the move into clinical services.
She has held a number of directorial and managerial positions in the industry working with leading companies including Quantum Research UK Ltd. and Packaging Coordinators, Inc. where she specialized in clinical trials packaging, global distribution, and laboratory development services.
As Clinical Trials & Customer Services UK Site Director at Packaging Coordinators, Inc., Sue has been instrumental in developing the company’s portfolio of harmonized clinical trials supplies pharmaceutical packaging services, ranging from clinical trial supplies for Phase I trials right through to commercial launch and post-approval studies.
About Packaging Coordinators, Inc.
The global healthcare industry trusts PCI for the packaging solutions that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches a year and over four decades in the healthcare business.
Leading technology and continued investment enables us to address global packaging needs throughout the product life cycle — from Phase I clinical trials through commercialization and ongoing supply. Our clients view us as an extension of their business and a collaborative partner, with the shared goal of improving patients’ lives.