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eBook: Pharma Serialisation – Where to Begin
1 November 2015 • Author(s): TraceLink
In response to increasing drug integrity concerns, over 40 markets – including the European Union, United States, Brazil, China, South Korea, and many more – have introduced track and trace laws to help regulate product as it passes through the supply chain. By the end of 2018, more than 75% of the world’s prescription medications will be protected by legislation.
As a pharmaceutical company you will ultimately need to master the different reporting and track and trace requirements for each country in which you do business; implement a solution to generate, store, and manage unprecedented volumes of regulated data; and exchange that data with all of your supply chain partners. Overall, it’s a daunting task. Where do you begin?
While no two countries have passed the exact same requirements, they all rely on one core component: serialisation. Serialising product in one manner or another is the cornerstone of all the regulations. The advent of serialisation will transform not just the pharmaceutical industry, but many core operations at your company. And all that change needs to happen in a very short timeframe: if you are not prepared to serialise product by the time a country’s deadline takes effect, you may not be able to sell into that market.
Over the next few years, at least a few people in your organisation will likely develop deep expertise on serialisation. But if you’re at the beginning of your journey, you need the basics: foundational content on serialisation to help you get started.
In “Serialisation: Where to Begin, an Introduction for the Life Sciences Supply Chain,” learn how serialisation differs from track and trace; key terminology; how to determine your requirements; what parts of your organisation it will impact; and how to begin to construct a preparatory timeline. The goal of this guide is to teach you to walk because – with dozens of deadlines coming into effect over the next three years – you’ll soon need to be able to run.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics