Drug Serialization and Supply-Chain Security - Pharmaceutical Technology

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Drug Serialization and Supply-Chain Security
As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 6

"It's not a technology-centric issue; it's about securing your supply chain," he says. "We don't have to embrace a specific technology, and that incentivizes us to look more closely at our processes." But in terms of industry consensus on technology and best practices, he admits, "We're still running around like chickens with our heads cut off."

As FDA continues to develop standards and regulations for improving supplychain security, manufacturers can take steps to guard against counterfeiting and diversion. Ilisa Bernstein, director of pharmacy affairs in the Office of the Commissioner at FDA, says companies should look at product-packaging measures and technology that fights counterfeiting and work together with partners.

"Knowing who you're dealing with, ensuring that supply-chain partners are legitimate and that those partners have stored, handled, and transported those products safely is important," she says. "It's not just about track and trace; it's not just about authentication —it's knowing who your partners are and practicing good distributor practices, good manufacturing practices, and good pharmacy practices."

With regulations in the works, companies must find ways to continue operations in the meantime. "For manufacturers, the biggest problem is that there aren't global standards, and the challenge is to comply with a mixed bag of requirements," says Joe Ringwood, chief operating officer of Systech International, a provider of packaging execution systems. He says companies are beginning to approach compliance as a global issue rather than focusing on a specific set of regulations (e.g., California's ePedigree requirements).

In terms of serialization, for example, a shift from compliance-based thinking to a focus on business optimization is underway for many manufacturers. Gaining a more granular level of data showing product movement throughout the supply chain and tying that information to business management software (i.e., an enterprise resource planning system) can help a company improve efficiency.

"Companies like having more detailed data. The forward-thinking companies look beyond the regulations and they realize that serialization is a foundation to optimizing business practices," says Andre Pino, vice-president and chief marketing officer at Acsis, a provider of supply-chain security software. "It's not just for fighting counterfeiting, but also for optimizing their processes, for example, managing outsourced partners." Greater visibility improves the ability to manage activities such as returns and recalls. Weaknesses in the supply chain can be identified and corrective measures can be taken.

Kim Loughead, director of solutions marketing for track and trace at Axway, a provider of collaborative business solutions, sees a similar pattern among pharmaceutical manufacturers and the shift away from a purely compliance-based strategy. "Lots of folks are focused on regulation strategies, but as they get further into it they realize there are other benefits, like gaining information about the cold chain and diversion, and they are shifting gears to a value-based approach," she says.

Technology trends

The application of security features to the dosage form is an emerging trend. This new layer of protection presents a tougher challenge for counterfeiters to duplicate. The ability to authenticate an individual dose of product can enable monitoring of a company's supply chain and can reveal instances of diversion.

"The greater frontier is on-dosage technology because we live in a world where everything is repackaged," says Dean Hart, executive vice-president of NanoGuardian, a company that places security measures on tablets, capsules, and vial caps. "On-dosage technology is becoming a must, not as a silver bullet, but complementary to on-package technologies," Hart says.

Companies are also starting to apply a layered approach to anticounterfeiting measures, in which a mixture of overt (e.g., holograms and color-shifting inks), covert (e.g., invisible inks and digital watermarks), and forensic features (e.g., chemical taggants and nanoencryption) are used together on the packaging and the dosage form. Tamper-evident technologies applied to the packaging will further strengthen a product's security.

"There is no single solution that is known to solve all different types of counterfeiting problems, so a risk-based approach needs to be taken in assessing the threats and relative security priorities for a given product portfolio," says Robin Koh, chief strategy officer for SupplyScape, a provider of software and consulting services for supply-chain traceability and collaboration. Koh says that some companies have studied the question of balance, asking, "What is the right balance between the security protections provided by a strategy, the cost to roll out that strategy, and the scalability of that strategy not only across all product lines but also across all supply and trading partners?" Finding this balance can help them make the right choices.


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