A “track-and-trace” bill, the Drug Quality and Security Act, was recently passed by the US Congress as part of the government’s effort to deal with counterfeiting of pharmaceutical products by requiring a tracking system (i.e., serialization). Ian Parsonage, director of serialization at Packaging Coordinators, Inc. (PCI), discussed issues that pharmaceutical manufacturers should understand about serialization with Pharmaceutical Technology.
PharmTech: What is required from the pharmaceutical industry as a result of the track-and-trace bill, and when will these requirements take effect?
Parsonage: HR 3204 is complex. There is a requirement, as of Jan. 1, 2015, for manufacturers to pass transaction records (i.e., bills of sale in either electronic or paper format) to the FDA. Three years after enactment, serialization at both saleable unit and case becomes mandatory; after 10 years, full supply-chain traceability will be required. The first requirement for serializing the case and the saleable unit does not explicitly state that the codes must be related, but all of the primary distributors in the US are requiring this of their goods, thus there is a need to aggregate. The federal law has preempted the California law, which required that 50% of products sold must be serialized before Jan. 1, 2015 and 100% by Jan. 1, 2016. The new deadline is three years after the federal act was signed into law.
PharmTech: What are some of the primary challenges in implementing a serialization system?
Parsonage: There are many significant challenges. One is having space on the artwork to carry the two-dimensional datamatrix code and the mandatory human readable information together with all of the required product and dosage data plus the national drug code (NDC) and other branding elements. Because of the variability of sizes of product packaging, serialization equipment needs to be custom configured for each package size and coding location. To facilitate aggregation, the serial code must be visible throughout the entire packaging process; dummy codes may be needed to help with this.
The volume of data and the reliance on information technology (IT) networks is a level never before encountered in most pharmaceutical plants, which forces the production network to move out of the domain of engineering into the IT realm. Another challenge is that business-to-business information must be shared in a near real-time fashion to facilitate the requesting, receipt, and commissioning of serial numbers together with their post-production status and aggregation detail.
PharmTech:What is a typical timeframe for implementing a serialization system?
Parsonage: The longest component of the leadtime is the provision of serialization equipment, which can be anything between 10 and 15 weeks depending on the complexity. Before purchasing serialization equipment, a company needs two to four months to review the product, artwork, and current packaging process and decide the way forward. After receiving equipment, a company needs three to four months to cover installation, commissioning, validation, and trialing. All in all, a company may need anything between 6 and 11 months from review to implementation.
PharmTech: What are some of the benefits companies can gain from serialization, outside of compliance with the law and avoiding counterfeiting?
Parsonage: Serialization can help manufacturers track their own product. Aggregating to a pallet level, for example, can enable a manufacturer to know exactly which packs of product were shipped to a particular customer or wholesaler. This, coupled with knowing the exact sequence of manufacture, can ease the investigation of a potential quality issue and lessen the market impact of any problem. It should, at least in theory, be possible to avoid a mass recall in the cases where a known portion of a production run is found to have a defect. The equipment used for producing the serialized packs can also collect a huge amount of data about the efficiency of a production line. These data can offer insights into where a line needs to be updated or processes need to be changed in order to increase efficiency and reduce costs.