By Jim Kerper
Signed into law late in 2013, the primary objective of the Drug Quality and Security Act (DQSA) is to better identify and trace — down to the package level — certain prescription drugs distributed in the U.S. The results will protect consumers from potentially dangerous pharmaceuticals, including those counterfeit, stolen, contaminated or otherwise harmful.
Under section two of the DQSA, the Drug Supply Chain Security Act (DSCSA) outlines steps that build an electronic, interoperable system to identify and trace drugs through the U.S. distribution supply chain. By 2023, manufacturers must be able to identify products via unique codes that can be read electronically, traced and used to verify the product, thus providing the tools for increased supply chain visibility.
In anticipation of meeting the requirements of the DQSA and DSCSA, product brands, contract manufacturers and distributors are working with the U.S. Food and Drug Administration (FDA) to establish track and trace programs to comply with these regulations. At the forefront of these programs is serialization, a process defined by the marking of non-predictive serial numbers or unique identification codes on each packaging unit. The serial number can be used to trace product across the supply chain, thwart diversion and counterfeiting and help protect the security of U.S. consumers.
Diversion, counterfeiting and recall
Regional economies are more and more integrated through new marketplaces, increased trade and globalization. The Internet is a prime source of falsified drug sales. Over 50 percent of products purchased on the Internet are counterfeit. These factors make it easier for counterfeiters to trade and transport falsified dugs. Having a way to combat counterfeiting is paramount in today’s global economy.
Giving all parties involved in the supply chain full visibility, as well as having updated database management with aggregation information, means there is immediate insight into where the product sits in the supply-chain process, thus reducing diversion and counterfeiting risks.
For the pharmaceutical industry, aggregation helps manufacturers define the relationship between single units, such as bottles, with cases and pallets. This system allows the receiver of the product to scan a single code and identify the exact contents of the entire shipment. As a company builds aggregation transactions, accuracy plays a crucial part in its success, and technology such as scanners and high-resolution cameras are critical to the process to capture product codes and ensure product legitimacy.
In addition to establishing successful anti-counterfeiting measures, track-and-trace programs help with FDA compliance and detour other fraudulent activities surrounding the supply chain, such as charge-backs and diversion. Layers of security, such as serialization; smart codes; dynamically changing codes from a known algorithm; and covert coding with ultraviolet or infrared inks; all provide added product security. In some cases, manufacturers can use up to five marks or more to safeguard products with extra layers of security.
Safety from packaging & printing
To help keep the supply chain safe, printing technology should be serialization capable, compatible with third-party controls and software, and have capabilities to print a scannable and robust GS1-2D data matrix as the main data carrier.
Equipment should integrate or interface with third-party controls or data-management software on the line and match up codes with the respective product. Marking and coding hardware for supply-chain management is determined by substrate and speed. Depending on what the job calls for, laser or thermal transfer overprinting (TTO) could be a viable choice. For clarity and high resolution in an easy-to-use cartridge-based system, thermal inkjet (TIJ) is a good option. All of these coding technologies give manufacturers the ability to print 2-D data matrix codes at high speeds and produce specialty fonts to help accurately mark a product as authentic.
Within an organization, cross-functional teams are often assembled in order to make sure the manufacturing process is on par with track-and-trace requirements. Individuals from packaging, operations, engineering, information technology and other departments within a company may form a taskforce to ensure that the products are adhering to legislation set forth in the DSCSA.
Choosing the right partner
While pharmaceutical manufacturers face many challenges in preventing diversion and counterfeiting and protecting consumer security, advanced track-and-trace solutions can help them take a layered approach to securing their supply chains. Choose the right partner, one that offers a deep well of marking expertise and also a wide range of solutions including intelligent coding (algorithms), overt coding (indelible laser marks) and covert coding (unseen to the naked eye using ultraviolet inks).
Additionally, it’s important to partner with a solutions provider that can work with many different substrates and container shapes, including bottles, the favored pharmaceutical packaging format in the U.S., as well as blister foils, tubes, vials, pouches, cartons and cases.
Jim Kerper is group sales manager, North America, at Videojet.
Videojet Technologies is a world-leader in the product-identification market for in-line printing, coding and marking products, application specific fluids and product life cycle services in the pharmaceutical, consumer packaged goods and industrial goods industries. Its technologies include continuous ink jet (CIJ), thermal ink jet (TIJ), laser marking, thermal transfer overprinting (TTO), case coding and labeling and wide array printing. Videojet has more than 325,000 printers installed worldwide. Its operations include over 3,000 individuals in 26 countries worldwide, as well as more than 400 distributors and OEMs, serving 135 countries.