Blue Sphere Health

Serialization and epedigree: 2012 – 2017 plan

The end of 2011 is almost upon us. The coming of the New Year marks three more years until the California epedigree deadline of 1 January 2015. This may be superseded by federal regulations but the ones currently under discussion have the same deadlines anyway. The CA / USA epedigree mandate is the first of several big requirements for traceability in pharmaceuticals. The implementation of serialization as part of the EU Falsified Medicines Directive is likely to come soon after, in late 2016 or early 2017. Collectively, these new laws will re-engineer the way the pharma supply chain works. There are other initiatives before then (Argentina, China, India to name but three) but as things stand today the big game-changers will be California (or its Federal equivalent) and the EU. Still, at least you have three years or more to get organised. Maybe, given the rough waters the economy is in right now, there is even an argument for executive management to save money by delaying some activities for another year, right? Wrong. As part of a consultancy project recently, we did an evaluation of the activities that need to go into an epedigree and serialization compliance program. We broke those down into discrete and measurable activities that individuals and departments would need to accomplish in order to be ready for the compliance deadlines. When you work backwards from 1/1/2015 and make some plausible assumptions about task durations and dependencies, you get a high-level Gantt chart for serialization and epedigree that starts in January. Not January 2013 or 2014, but this coming January. The highlights of the chart are here: Serialization and epedigree planner 2012-2017 The big ticket Capex spending on software and hardware can just about be left until 2013 if you have a degree of risk tolerance, but there are a lot of preparatory things you need to do before the guys with wrenches and servers get to work. These must start now if you haven’t already got going and may well impact Opex next year. The sort of activities that take a surprising amount of time are: Conversion to GS1 numbering Printing variable data on packs is often seen as the main problem in serialization. However, arguably an even bigger challenge is to sort out the fixed data. Information such as stock-keeping unit (SKU) codes and other internal reference numbers is often housed in disparate places. There may be multiple “synonyms” for the same item as systems have grown by merger and acquisition, or due to divergence of numbering practice between regional offices etc. As a pre-adaptation step for GS1-based traceability systems, all of these numbers must be harmonised and migrated to specific standard formats. SKU numbers, for example, need to move to Global Trade Item Numbers (GTINs) so that there is single numerical reference for each item type worldwide. Do not underestimate the amount of time and resource that this takes. I have heard several conference presentations recently from top twenty companies who took 12 to 24 months to get this right. Vendor selection and procurement There is a risk of a version of the Y2K issue in pharmaceutical serialization as the key deadlines approach. Vendor resources are finite and may become stretched. If you wait too long to select and order your equipment and software you may have to wait an uncomfortably long time. Strategy As military leaders from Sun Tzu to Montgomery have noted, time spent on reconnaissance is rarely wasted. Take the time to get the right strategy and get management backing for it. One serialization executive described his company’s juggling of manufacturing capacity whilst installing serialization capability as “like three-dimensional chess”. It is not something that can be left to individual plant managers. Conclusion This post is not an exhaustive analysis of serialization and epedigree but I wanted to highlight the need for urgent action in 2012. There is a lot to do but Blue Sphere Health can help you to get there. We provide consultancy at all stages of the process, from initial management workshops to training to implementation across sites. To discuss your needs in confidence, please contact us now to plan a call or meeting. Photo: alancleaver_2000 from flickr

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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.


Pharmaceutical Anti-Counterfeiting book