As global manufacturing regulations tighten to weed out counterfeit drugs from supply chains, suppliers have to come to terms with new demands being placed upon serialisation. World Pharmaceutical Frontiers talks to Jim Cummings, vice-president for the Americas at Adents, about how the company's Pharma Suite is streamlining new input demands for the production line and helping manufacturers make significant long-term savings.
International concerns about the traceability of drug products have reached fever pitch in the last few years, leading to a range of laws and regulations being passed across the world to impose new serialisation requirements on the part of pharmaceutical manufacturers.
"About 40 countries have enacted new laws," says Jim Cummings, vice-president for the Americas at Adents, touching on a new, deceptively complicated problem confronting drugs manufacturers the world over: that of complying with an ever-changing regulatory environment, taking into account a variety of different scopes, event reporting requirements and degrees of information exchange.
Adents Pharma Suite assures just that. As software that can be installed on a drug manufacturer's production line, it can ensure near-instantaneous compliance with new regulatory requirements in a variety of national jurisdictions. "With it, we're able to configure all product IDs on site," says Cummings. "Now, our customers do not have to go directly to the packaging line to make any changes. They can do it in one location, without any custom code."
Adents Pharma Suite functions via the presence of two key products. The first is the 'pilot' software station, which oversees the devices present on the line, including the printer, camera, scanner and reject stations. "A pilot station can be dedicated to implementing item serialisations, be it cartons, bottles, or sachets," Cummings says. "Alternatively, if there's a need for new bundle, case or a palette aggregation, we would have a pilot software station at each of the lines dedicated to the job."
What distinguishes the Adents Pharma Suite from other similar offerings in the marketplace, however, is its second constituent component: the 'supervisor' software server. In addition to being able to import or create new serial numbers at site level, this greatly simplifies the way in which new work orders are generated. "The flow of data starts from the client's ERP or MES system," says Cummings. "Supervisor would then download to the appropriate pilot station at each packaging line a work order list, which is the only interface the operator will have. That list will appear on their screen, and they will choose the appropriate work order. Supervisor will then automatically send the instructions to the printer, camera or any other device specific to that work order."
Customers no longer need to shut down an entire line to implement new setups, meaning massive time and cost efficiencies can be made over the long term. Furthermore, the suite enables users to produce detailed production reports and serialised data in several standardised formats with all designated third parties, guaranteeing a high level of interoperability. Any changeovers are therefore managed seamlessly; wholesale reconfiguration of production processes is a thing of the past.
Perhaps most importantly, all of this is achieved through software alone. "Adents is not in the equipment business," affirms Cummings, referring to the practice of many of the company's competitors in pushing for proprietary equipment to be installed on-site and some measure of hard-coding for good measure. "We don't do that. We can achieve installation in one location, and all of it can be done offline, at our site server."
It's a system that Cummings is confident will provide Adents' clients with a solution perfectly adapted to the shifting regulatory sands of international pharmaceutical manufacturing: "Change is inevitable, and what we provide is a very flexible, powerful system that's easy to use, and causes minimal downtime, change management, revalidation and IT governance."