INSIDER INSIGHT


relationships. Thus, expect diversity and plan for it by isolating serialization diversity in your global IT architecture and identifying potential constraints it places in your global supply planning.


Since serialization regulations will vary from country to country, Life Sciences companies face unprecedented complexity, cost and risk in how they implement strategies globally.


• United States: The Drug Supply Chain Security Act (DSCSA) mandates that manufacturers begin serializing all drug products at the saleable unit and case level for the U.S. market starting in November 2017, with repackage deadlines beginning in 2018. With DSCSA’s January 2016 lot-level traceability deadline behind us, pharmaceutical companies are turning their attention to full drug serialization. DSCSA requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by 2017. Given everything that needs to happen by then, from altering highly regulated packaging and distribution processes to addressing enterprise-wide IT, this is an aggressive implementation timeframe. At the same time, wholesale distributors and other supply chain companies should be gearing up for end-to-end serialization testing with their manufacturing partners well in advance of the deadline to allow time for any necessary adjustments.


• European Union: Manufacturers serving the EU are preparing to meet serialization requirements at the package level that are expected to start in early 2018. These requirements include supporting both global and national identifiers and following strict uniqueness regulations. With the publication of the Delegated Act on safety features, those who manufacture, sell, or dispense medications in the EU have until February 2019 to comply with new track and trace regulations outlined in the Falsified Medicines Directive (FMD).


FMD compliance creates some unique challenges. The main requirements involve serialization, compliance reporting, and verification. Medications in Europe are generally packaged and sold at the “unit of use” level, so the volume of product that needs to be serialized and the magnitude of transactions will be two to five times what companies will see in the U.S. where the saleable unit is in larger bulk quantities. Overall, the universe of data to be produced, managed, and reported on will be massive, with the added complexity that each EU Member State is provided flexibility to apply their own unique requirements.


• China: All levels of product – unit, bundle, case, and pallet – must be serialized with a government-issued number, and aggregation is a regulatory requirement. Pharma companies must run a query on a Chinese government system in order to initiate and capture the serial numbers, which are then provided to the packaging lines. After the serial numbers have been deployed, manufacturers must report back on product events.


There are multiple complications associated with Chinese reporting requirements. First, all reports must be manually uploaded to the China FSDA system by someone based in China; the upload cannot be managed remotely from another country. In addition, there is a size restriction of five megabytes for the uploaded report. If you are reporting on a large batch of data, your file size can easily exceed that, in which case you will need to follow strict guidelines on how to split up the file, what header information to assign, and the sequence in which to upload the multi-part report.


While serialization - the global track and


trace regulations to protect patient safety and ensure product integrity - will be a standard requirement for the global drug supply by the end of the decade, the serialization requirements themselves will be far from standard.


• Brazil: RDC 54 regulations establish very complex new serialization requirements for all registered drug products that started phasing in starting in December 2015. Manufacturers will need to apply unique Brazilian IUM identifiers into 2D DataMatrix barcodes for each saleable unit, serialize each transport container (case) and ensure aggregation relationships.


Brazil has the most complex serialization track and trace regulations in the world today. Compared to other global regulatory requirements, Brazil is a hybrid model: with their serialization, tracking, and government reporting, they are asking for a little of everything. Under their law, the primary burden for compliance falls on manufacturers, with wholesale distributors and pharmacies sharing some reporting responsibility.


In Brazil, the manufacturer is responsible for tracking drug product movement from the point of manufacture to patient dispensation. As a manufacturer, every time your product flows from wholesaler to wholesaler to pharmacy, each of those parties has to send back data into your system, and then you need to provide it all to ANVISA. The challenge for manufacturers has been to establish reliable connections with both direct and indirect supply chain partners. And similar to the U.S. government, Brazil’s government is not prescribing how compliance information must be shared between companies, but is instead leaving it up to industry to decide.


This high level overview of current global supply chain topics portrays the complexities of conducting a global clinical study. Alongside the complexities, there have been tremendous improvements by both governmental agencies and Life Sciences companies. Capsugel’s acquisition of Xcelience in January 2016 demonstrates the value that specialized design, development and manufacturing companies are placing in continued investment and innovation in best-in-class clinical supply solutions.


Past and ongoing global process improvements speak to the sense of pride our industry exudes, knowing that collectively, as a Global Team, we are able to improve the lives of patients. The discovery and approval of life saving drugs is not an easy process, however, definitely one of the most rewarding.


Pharmaceutical Outsourcing | 34 | July/August 2016


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54