Counteract the counterfeit

As the market for generic opens up, the industry faces a new backlash of counterfeit products. Hans Bijl outlines how considering the right influences could lead to a solution – and confront the very nature of counterfeit goods.

“Skilled staffing, executed at the same time and presented in all of the relevent regions will be the key decisive factor to the success of a company's serialization roll out.”
-Hans Biul

Pharmaceutical and life science industries are facing serious challenges in their fight against counterfeited products. The life and health of the patients must be protected and the damage to reputation and financial detriment related to brand image, product recalls, lawsuits etc. shall be avoided.

Implementation of serialization, and tracking and tracing solutions in the packaging line is the answer. But what aspects influence the solution and need to be considered to come to the right decision?

Different regulations apply for different regions

The way regulations are being implemented in one certain region can differ enormously from other regions. Think of a company that runs packaging sites in all affected parts of the world. They need to keep up with the regulatory specifics of each country in combination with often rather volatile timelines. One of the most obvious examples here is Brazil, where after a number of earlier announcements, 2011 now seems to become crucial. But until now with a system of serial number handling and application based on government supplied labels, that is a true challenge for any producer serving the Brazilian market.

Process- and technical requirements

As the first rounds of investment were driven by the need of straightforward 'serialization' (or even less, think of French Coding), the upcoming regulations often involve more complex data-handling requirements like aggregation of different levels of packaging, but also the incorporation of specific serialization functionality into new or existing processing of work orders and batches.   

Different packaging line types, with different levels of automation

Whereas in the western world often secondary facilities have been automated to the latest standards available, including sophisticated MES functionality and/or line integration, in emerging countries like China the level of automation could be anything from non-existing to exactly that same level of sophistication as in Europe or the US;

Levels of ERP: Different systems, or none at all, will affect the global standardization of ERP integration - and in the end the future integration into one single, global ePedigree topology.

Not all products and/or regions are affected: A facility where different products are being handled, or from which different countries are being served. This will certainly affect the required line and site flexibility.

Effect on overall equipment effectiveness (OEE) and plant downtimes

As already mentioned, implementing a serialization solution in a packaging site could affect the line of site key indicators, from the perspective of the actual implementation - e.g. the time to retrofit the line or replace existing ones, or by influencing the required production capacity (e.g. items/min). But it does not necessary have to, if innovative designs are used. 

Timeline

The often short-term issuing of local regulations mean that time pressures on implementation can be severe - putting a strain on all stakeholders involved.

Resources

Perhaps one of the most critical issues - although not the one most obvious: If the massive wave of regional serialization legislation truly comes up, with its maximum expected to be reached around 2014/2015 when both the US as well as the EU implement their set of regulations, the demand for qualified staffing will be huge - putting another strain on a company's ability to handle the legislation

As a result, the industry is looking more and more for strategic partnerships with suppliers that are actually able to handle this globe-spanning demand in an adequate way. The actual solution a supplier offers should be able to deal with all the technical challenges mentioned. Preferably build in a modular, scalable way around existing industry standards, the ideal solution is robust, open, and available on a global scale, around the globe.  

Perhaps more important than the actual technical solution is the way a supplier is able to handle the variety of different local and company requirements. Skilled staffing, executed at the same time and presented in all of the relevant regions will be the key decisive factor to the success of a company's serialization roll out.

About

Hans Bijl is Sr. Business Development Manager at Siemens Industrial Automation Competence Centre Life Science. Over the last decade, he has been working in the Life Science area. Since 2008, his assignments have included the the corporate initiative around Pharmaceutical Anti-Counterfeiting measures and Supply Chain security, including serialization.