Effective strategies to ensure regulatory compliance and best practice
With drug counterfeiting on the rise and regulatory deadlines fast approaching, the pharmaceutical supply chain will soon be at a critical point as it strives to ensure patient safety. From drug manufacturers to distributors, all supply chain partners will need to make crucial decisions to upgrade their production lines to comply with the Drug Supply Chain Security Act (DSCSA), Falsified Medicines Directive (FMD) and emerging market traceability deadlines.
Evolving industry regulations for the implementation of industry serialisation present real and global challenges for both pharmaceutical and biotech companies, particularly in light of imminent compliance deadlines with the DSCSA in the United States, as well as European Union requirements and those of emerging markets such as China, South Korea, Brazil and others. Under intense pressure to meet these regulatory timings, some of the industry’s brightest minds shared their experience and best practices regarding implementing an effective serialisation strategy at a dedicated Serialisation Forum event in London, UK.
Hosting the event, leading pharmaceutical outsourcing services provider PCI Pharma Services collaborated with Antares, Crest Solutions and Multi-Packaging Solutions (MPS) to highlight the need for all manufacturers, distributors and supply chain partners to upgrade their production lines in compliance with the forthcoming traceability deadlines. Opening the session, Christoph Krähenbühl, Senior Director at leading European Serialisation consulting firm, 3C Integrity, gave his insights on preparing for the industry’s pending global serialisation requirements. 3C Integrity recently joined forces with leading US consulting firm Excellis Health.
Ian Parsonage, Senior Director of Global Serialisation at PCI, shared his expertise on lessons learned, as well as best practices in serialisation. A broad and complex client base and several years of experience has enabled PCI to develop a specialist approach to serialisation. PCI has been actively serialising commercial products for both domestic and international markets for the past 5 years, with products destined for North America and Europe, in addition to emerging market geographies such as South Korea, Turkey, Brazil, China and others. In total, PCI works with more than 250 customers in packaging suites across 17 sites in the USA and the UK — supporting more than 8000 packaged medicine products destined to more than 100 global countries.
This experience has led PCI to identify a number of common challenges, any of which may lead to significant delays:
Working closely with its technological industry partners to help support its clients in advance of meeting both US DSCSA and EU FMD implementation dates, PCI recently announced a significant expansion of its market-leading serialisation capability, tripling its capacity across its global network.
PCI has partnered with Antares Vision, Marchesini and Domino for this latest installation, utilising Antares’ leading serialisation platform and technology architecture across a variety of serialisation technology platforms and applications. The multisite installations support a variety of drug delivery forms, including bottles, unit cartons and parenteral kits, as well as unit dose wallets and child resistant/compliance-prompting packaging.
In addition, serialisation technologies support ancillary and tertiary packaging, corrugated shippers and palletisation solutions to support multilevel product aggregation. Although aggregation is technically not a requirement for compliance with the 2017 DSCSA deadline, PCI strongly supports the advanced use of aggregation to realise significant benefits in packaging operations, as well as the broader pharmaceutical supply chain.
Ian Parsonage explains further: “Tracking products through the supply chain by aggregating to cases and then to pallets enables a business to know what is physically on each pallet. When a pallet is shipped to a lower level of the supply chain, you know precisely which serial number applies to that level. If you’re shipping at this level, you know exactly what’s in its case. So, if any market complaints or concerns arise, the product serialisation enables you to trace back to identify potential issues — including any indications of potentially illicit or fraudulent activity.”
“For any manufacturer such as PCI, the ability to aggregate — to know that the product that you’re putting into the case is correct, and of the right quantity and quality — is critical to really reducing the impact of serialisation; quite simply, it stops human mistakes. The automated case packing process picks up any errors and will not allow you to complete the case, so operational efficiencies increase as human error is reduced.”
“PCI’s production procedures are underpinned with robust training and stringent quality control. We set ourselves a standard of 100% reconciliation of serial numbers, so if we produce 9500 of 11,000 products, we need to know where that other 1500 went. By aggregating the products, it’s very much easier and more accurate for us to manage the serialisation process,” he adds.
“There are time efficiencies to be gained too: a batch of 400,000 products could take 6 days to run. To find you’ve made a mistake during or at the end of that time could take you a further 6 days to resolve.”
Commenting on the serialisation challenges facing pharmaceutical and biotech companies, PCI Vice President of Global Engineering, Ken Richardson, says: “Serialisation preparedness is the topic on everyone’s mind in the pharmaceutical industry. Having actively developed and supported serialisation during the past 5 years with numerous commercial applications around the world, PCI has a significant body of knowledge to share with clients. With these key learnings from practical applications of serialisation and anticounterfeiting technologies, we have positioned ourselves to support our clients as they start to truly develop their own global serialisation strategies.”
”The spotlight is on the industry to meet the November deadline and PCI has directed an amazing amount of financial resource, technological expertise and effort to help our clients be prepared. This latest investment in our global serialisation initiative and brand security programme capability is considerable, and features what we believe are truly industry leading technologies.”
Parsonage’s presentation at the Serialisation Forum event was complemented by Frank Madden, Founder and CEO of Crest Solutions, who provided advice for pharmaceutical firms on succeeding in serialisation strategy and implementation. Crest Solutions operates as a partner integrator for Antares Vision Serialisation technologies in the European market. Xyntek Inc. operates in the same capacity in the US. Both firms feature extensive history with successful installations at leading pharmaceutical firms and CMOs.
Attendees at the Serialisation Forum event also heard from key sector leaders at leading pharmaceutical companies during an industry roundtable session wherein practical experiences and best practices were discussed.
Full-service print and packaging supplier MPS provided a demonstration and forum for leading anticounterfeiting material technologies that can complement serialisation strategies. A live demonstration from Antares and Crest Solutions also helped audience members to absorb further knowledge about serialisation with the help of imported production equipment installed at the venue.