CheQ this out: Travtec’s CheQAssure system automatically checks the details held in individual bar codes
If there is one thing we can be certain of in life, it is that nothing is certain! So although pharmaceutical companies are currently focused on ensuring they are able to meet the coding requirements of the Falsified Medicines Directive (FMD) by its 2017 deadline, most commentators would acknowledge that this will not be the end of the matter.
Regulations and legislation in any industry are constantly changing and being updated or refined. Implementing them across more than one country only adds to the complexity. And of course, while the FMD covers the European Union, today’s global market often means companies have to be aware of more than one set of regulations and adapt their systems and procedures accordingly.
Even while the requirements for the FMD were being discussed, some countries were already implementing their own regulations. Turkey for example was the first in Europe to introduce Track & Trace into the pharmaceutical industry in 2010. And a 2D coding system with the CIP 13 coding requirement was implemented in France from January 2011.
Further afield, California is now in the process of introducing an E-pedigree for prescription drugs.
The new Electronic Product Code Information Services (EPCIS) for pedigree track and trace requires a record, in electronic form, containing information regarding each transaction that results in a change of ownership of a given drug - from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, to the final sale to a pharmacy or other person furnishing, administering, or dispensing the drug. This has to be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution.
The Californian model could become worldwide in the coming years. This means it is essential that companies currently seeking to invest in equipment to meet the FMD think carefully only about their immediate requirements and what they may need – and where they may be supplying – in the future.
Future-proofing will be a key consideration in any anti-counterfeiting system – but the more practical criteria should not be ignored either.
Selecting the right printer is only the start of finding an appropriate coding solution. While today’s high resolution printing technologies can deliver the quality of bar code necessary for the automated serialisation and verification systems, it has to be recognised that they will not always be printing in ideal conditions. Substrate, line speed and factory environment also need to be taken into account. And for a system to work effectively, it will be necessary not only to have an easily readable code but also ensure that it is placed correctly on the pack.
What is equally important is for the pack to be completely controlled during the printing process. This requires an appropriate feeding and handling system. And for efficient quality control purposes, a vision system needs to be incorporated as well.
And since none of these pieces of equipment work in isolation, it is vital that they are fully integrated and able to communicate with each other as part of seamless operation. In other words, the effective coding of the pack becomes part of a specialised product handling solution comprising all these elements along with a fail to safety reject system.
This means that an anti-counterfeiting system should not be regarded purely as an IT issue. Installing equipment is not as simple as merely placing it on the line and expecting it to work first time. Equal attention has to be paid to the engineering aspect; otherwise there is the risk that problems will continue to arise in the supply chains.
However, pharmaceutical manufacturers also need to ensure that they have the flexibility and freedom to continue to choose the appropriate equipment that is right for their business. The focus on the need for integration means many suppliers are now offering ‘complete’ solutions comprising not just the various pieces of equipment but also the software systems and packages that allow them to work together.
This may be a very tempting offer at first glance but there is a danger of companies then being ‘tied’ to one particular manufacturer or system and this can have a detrimental effect as markets develop and business focus and requirements change.
All of which means companies must choose carefully – not just the equipment but a collaborative partner who can offer the appropriate advice and guidance at every stage.
In this way, their operations will be properly future-proofed.