Given the staggered deadlines for Unique Device Identification and a lengthy phase-in period for U.S.-market pharmaceutical item-level serialization, healthcare product manufacturers have time to address some of the challenges in implementation. Solutions providers that exhibited at Pack Expo International and Pharma Expo 2014 shared their approaches in handling data and the packages themselves in an effort to provide the tight control needed for dependable line performance.
Aesica Pharmaceuticals S.r.l, the Italian division of contract development and manufacturing organization Aesica, is launching an integrated serialization system from QAD for two pharmaceutical products for the Chinese market. The project at Aesica's site in Pianezza reportedly complied with new requirements from China’s Food and Drug Administration (CFDA) that cut the serialization implementation deadline to just three months from its original 12 month timeline, the CDMO reported in a press release.
As FDA works on developing standards for the interoperable exchange of tracing information for finished human prescription drugs, questions about packaging are already being raised. To prepare for implementation of the Drug Supply Chain Security Act, the agency held a public workshop in May during which it discussed with stakeholders the exchange of transaction information, transaction history, and transaction statements each time drugs are transferred.
As the U.S. representative for Tri-Star Technologies and CertiRx, Key International is offering their technologies for detecting counterfeit pharmaceuticals, medical devices, and more. Tri-Star Technologies provides a cold laser marking system that can mark individual tablets, capsules, soft gels, or other pharmaceutical products. The indelible mark reportedly does not adversely affect the product. Patients can then obtain information about the marked individual tablets or capsules by using the CertiRx app with a cell phone by taking a picture of the dosage form.
Global pharmaceutical contract developer and manufacturer Aesica reports that it has introduced serialization services and begun commercial production of two anti-allergy product lines for the Chinese market at its Pianezza site, Italy, for a global, multinational client. The implementation took under six months to complete, with the first production of serialization batches just commenced, the company reports.
The Drug Quality and Security Act (DQSA) of 2013 may have reset the clock for pharmaceutical track and trace and serialization, but there’s little reason for manufacturers to pause. Despite the progress made by industry pioneers and pilot programs, there are still “tremendous unmet needs,” observes Tim Marsh.
Regardless of the regions in which your company markets pharmaceuticals, you are probably preparing for changes in product identification. A new U.S. federal law has preempted California’s electronic pedigree requirement, giving companies more time to implement new identification approaches for that market, but other requirements around the world are phasing in. And given the globalization of the pharmaceutical supply chain, drug manufacturers undoubtedly are looking beyond individual markets and searching for strategies to maximize technology investments.
“Introduction of counterfeit products in the normal international supply chain poses particular issues for pharmaceutical companies, both from direct risk to their customers and to their own reputation within what is a highly competitive industry,” cautions Charles A. Smith, senior systems consultant at Horizon. “There is a direct cost of product recall, where positive identification of counterfeits can be difficult, without the identification and data handling capabilities provided by serialization.”