Issue link: https://www.e-digitaleditions.com/i/977310
Tablets & Capsules May 2018 9 tation began on the batch level. The law required manda- tory serialization of primary packaging by November 2017. While the DSCSA has remained unchanged, in 2017 the FDA announced that it would delay penalties for noncompliance with the law until November 2018 to give pharmaceutical companies more time for implementation. As the FDA's enforcement delay indicates, meeting the DSCSA's serialization requirements has been challenging for many pharmaceutical companies. The biggest chal- lenge, however, will come in 2019, when pharmaceutical wholesalers must also know the serial number—either in the form of the National Drug Code (NDC) or the Global Trade Identification Number (GTIN)—of each individual package and outer packaging. By the end of November 2023—exactly ten years after commencement of the DQSA—the complete connection and aggregation of the drug product supply chain will be implemented. Anti-counterfeiting efforts around the world The European Union's Falsified Medicines Directive 2011/62/EU, which came into effect in February 2016, requires pharmaceutical companies to use coded packag- ing with unique serial numbers for all prescription drug products starting February 9, 2019. As in many other countries, the serialization requirement is a 2D data matrix code (Photo 1) that contains a randomized serial number, the batch number, and the expiration date, as well as other data, as required. At the same time, the EU demands a second level of security in the form of a tam- per-evident closure such as an integrity seal or glue, as described in the European standard EN 16679:2015-03, As a result, pharmaceutical manufacturers and contract packagers are faced with the challenge of selecting the appropriate technologies to meet these laws' require- ments and integrating those technologies into their exist- ing production and packaging processes. In this article, I'll discuss the requirements of these drug safety laws and explain why the safest option for meeting these require- ments is to adopt a holistic approach consisting of a scal- able machine-and-software concept. The Drug Supply Chain Security Act On November 27, 2013, the US adopted the Drug Quality and Security Act (DQSA). Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), outlines the steps pharmaceutical companies must take to imple- ment a serialization system that identifies and tracks drug products distributed in the US. In early 2015, implemen- Photo 1: The 2D data matrix code must contain a randomized serial number, the batch number, and the expiration date, along with any other required data. Figure 1 Levels of serialization and aggregation Station Control Line Control Production Control Enterprise Control Data Management System data-handling serialization aggregation bottles / cartons bundles / cases / pallets warehouse / CMO / mobile solution Serialization modules Track-and-trace software Rework Aggregation modules