What’s in a (Unique) Number?

Over the past eighteen months I’ve been contributing to a hefty tome which focuses on supply chain management in the pharmaceutical sector, specifically looking at some of the regulatory issues associated with information systems and information technology.

Amongst the issues I identified as still requiring resolution was the need to be able to more effectively track products through the automated supply chain in order to counter the growing problems of counterfeiting, to reduce dispensing errors and to better support product recalls.
The good news is that in the time it has taken to write, review, edit and publish a book there has been significant progress by various industry bodies and regulators in defining what is needed in terms of:

• Uniquely identifying product at multiple levels, down to the final package or device,
• Establishing databases to share information and reduce duplication of data
• Leveraging existing standards such as GS1 Healthcare Standards

This not only includes drug products but also medical devices and while there is still a way to go with respect to international harmonization the increasing adoption or incorporation of standards such as GS1 means that it should be possible for manufacturers to develop internal identification codes that can be used internationally in the commercial supply chain and also meet the various requirements of different regulatory bodies.

While there is still a long way to go with respect to tackling specific issues such as how to label a re-usable, sterilizable medical device or how to label combination products it seems as if solutions are within the grasp of the industry – a fact borne out by the number of large pharmaceutical and medical device companies now investing considerable sums of money in developing solutions.

Regulators are accepting that any regulations should be indepedent of any specific technology and that sensible exceptions (or alternatives) may be required for specific product profiles or devices.

However, to truly develop and deliver workable and cost effective solutions it is necessary to look beyond the basic information technology that assigns and registers identification numbers, prints and scans and compiles data bases.

Much of the discussion is currently being driven by technology vendors who have admittedly gone a long way to making such solutions possible. However, there appear to be very few technology vendors who are looking at the big picture. It also appears that individual pharmaceutical and medical device companies focus upon specific aspects of the full end-to-end solution, depending on the specific experience and ‘hot buttons’ of the teams looking at these solutions. While some teams focus on how to use RFID others are concerned about how relabeling should be managed, but I've seen relatively few companies putting everything together to deliver not just regulatory compliance, but real business advantage.

While information technology will of course underpin any serialization, track ‘n’ trace or electronic pedigree solution it is information systems that will deliver efficient and cost effective solutions.

This requires that Regulated Companies look beyond the printers, laser etching, label stock, etc and take a look at the strategic information flows and business processes that will be needed to make these technologies work as a business solution.

This requires a strategic review of:

• Product master data management, at multiple levels and across all geographies - addressing the critical issues of consistent product codes and the federation and synchronisation of products codes between systems,
• Serial number allocation, management and security on a global basis - remembering that real time solutions will need to work even while the Internet connection to some central database is down,
• Changes to packaging and labelling operations, which may restrict the flexibility that some organizations are used to - it will no longer be possible to assemble-to-order or label in country unless unique serial numbers can be generated at the right point in the supply chain,
• Modifications to business processes to support serialisation - including necessary changes to supporting transactional applications such as MES, ERP and CRM systems,
• Integration of systems ranging from printing, labelling and scanning systems at the bottom end, through MES and into ERP systems at the top end – and the realignment of the supported business processes,
• Collaborative working with third parties including contract manufacturers, customers and regulators – ensuring that identification data is available to trusted and authenticated users while assuring the security of individual serial numbers. 

These key business challenges need to be addressed while at the same time tackling the necessary information technology challenges. As even small pilots have discovered, relying on people to populate this data is extremely time consuming and inefficient - in many cases we're talking about maintaining tens of thousands of product codes and serial numbers into the hundreds of millions. To work properly solutions will need to rely upon internet services and service oriented architecture (SOA) – and area where the Life Sciences industry has been lagging behind other industries.
With regulatory deadlines (e.g.now looming in the US and Europe Life Sciences organizations are now starting to address the issue seriously – but let’s just hope that it isn’t too late. While it is certainly possible to implement partial solutions in time to meet key regulatory milestones unless these issues are tackled at a strategic business level the cost to industry may well outweigh the benefit in terms of risk mitigation.