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Pharmaceutical Manufacturing and Packing Sourcer

Act Now, Save Later

Falsification in drug manufacturing and supply chain has increased across the world at an alarming rate. It has reached the point at which patients' health is now potentially under threat, specifically for those requiring drugs to treat critical illnesses or those ingesting drugs with illegitimate or ineffective ingredients. Furthermore, the rise of counterfeit drugs entering the supply chain has an equally damaging effect on pharmaceutical manufacturers, not to mention the implications that cheap, falsified versions of medicines entering the legitimate supply chain are having on the reputations of genuine suppliers.

Therefore, the European Commission's Falsified Medicines Directive (FMD) should be welcomed by the industry, with the legal framework enacted with effect from 1st January 2013. The measures introduced by the Directive will apply generally to all prescription products unless they are specifically exempted, with an aim to regulate, control and monitor the supply chain of drugs through the full lifecycle. However, what has become a concern for many manufacturers is that from 2017, once all parts of the Directive come into force, suppliers failing to comply with any aspect of the above will no longer be legally permitted to market their products in Europe. All eyes are focused on both manufacturers and suppliers to see who will make the first move towards a solution. Both existing and new technologies, as well as a close look at best practice from other sectors, will help guide companies to a successful way forward, with a clear focus on retaining optimum operating efficiencies.

Provisions to be Met

There are a number of key general provisions under the FMD. Each person or organisation in the supply chain must disclose its entire establishment information to the competent authority, along with a complete list of products and their respective valid marketing authorisation from the European Medicines Agency or other relevant authority in a European Economic Area member state.

A system of serial numbers must be adopted by each manufacturer to enable verification of a drug's authenticity at pharmacy level. This should allow pharmacists to determine whether a drug had been recalled or previously dispensed, allowing for interception of falsified medicines that have entered the legitimate supply chain before they reach the public. Manufacturers will also be required to provide a unique identifier as an obligatory authenticity feature on the outer packaging of prescription medicines.

Therefore, a system to identify false representations of products - particularly at an individual package level for high-risk products - will need to be introduced by all manufacturers and suppliers, who will then also be required to establish and document supply chain traceability. This is obligated to be formalised, and will be subject to regular audits.

All supply chain parties will be required to declare the name, address and qualifications of persons responsible for overseeing activities in the manufacture, importation, distribution or indentation of pharmaceutical products, as well as the quantities and end use of active substances and the protocols in place to record and manage quality.

The Challenge Ahead

Meeting the requirements outlined above is a significant obstacle for pharmaceutical manufacturers, both technically and logistically. Firstly, the majority of coding equipment in deployment at present does not have serialisation capabilities. Secondly, any new infrastructure that is required will need to ensure that an individual physical packet of medication's associated data remains intact and linked throughout the entire supply chain - from leaving the manufacturer to being dispensed at pharmacy level.

With such dramatic and far-reaching protocols to implement by 2017, requiring entire database systems to be created, stored and managed to handle this data, what will be critical for manufacturers, and those tasked with designing and executing a solution, is controlling the impact on production. With many pharmaceutical companies operating on highvolume production models, even a minimal disruption to manufacture through downtime of systems could cost businesses dearly.

Lessons from Other Industries

It is worth taking a look at other industries facing devastating results from counterfeiting, such as the luxury clothing market, in addition to ones such as food with highprofile and equally strict protocols over track and trace, specifically animal products. Both of these sectors have developed innovative systems to identify the authenticity of products through coding and labelling that supersede the supply chain.

For example, the luxury designer handbag and clothing sector suffers not just from counterfeit products penetrating the market, but also from a rise in the number of convincing, false products being returned to stores for refunds. A number of high-end design houses are investigating technology which will embed discrete identity data into clothing and accessories so that genuine goods can be tracked and identified as counterfeit if they try to re-enter the legitimate supply chain. These 'smart tags' can contain and carry a wealth of data that is very difficult to replicate or alter by criminals - using much the same radio frequency identification (RFID) technology as casinos embed into gambling chips to detect counterfeits. Already in use to track goods through the manufacturing process, RFID technology is now cheap and small enough - and even washable enough - to have a wider-reaching use once the goods are outside of the warehouse.

The recent horsemeat scandal also highlights the importance of watertight track and trace within the food industry, which already mirrors many of the protocols faced by pharmaceutical manufacturers and logistics handlers. Many specialist technology companies provide solutions to protect both food and pharma products through the global supply chain not only from theft or damage, but also from the counterfeit process.

Existing Technologies

At present, there is not a ready-made, catch-all solution to wrap up this raft of new protocols into a fully-formed, unintimidating system. However, manufacturers should be reassured to know that all of the elements required for track and trace and labelling and coding do already exist - and are probably already in place. The components just need to be coordinated and a database and data management system created to handle much of this information automatically and without the need for costly manual processes.

Warehouse management technologies, including radio frequency scanning, 2D Matrix barcodes and sophisticated automated pallet labelling systems, allow for a large amount of data to be stored on individual packets, which can be read by systems to create a bespoke and individual pallet or large unit label. This ensures that all of the specific data required by the FMD can be stored discretely on individual packets, as well as larger cases, so that should the unit or pallet be split during the supply chain, that information will still remain intact and accurate. Full automisation through the coding and labelling process ensures that errors in identification are virtually eliminated, and detection of misidentification can be very sophisticated. The good news for manufacturers is that many of these technologies will already be up and running within their current production process. All that will be required is to adapt the data that will need to be stored on the labelling. The bigger challenge lies in creating a counterfeit detection process, as well as linking up to a database and information management system to process and store the track and trace information.

Industry Standard

What we may see emerge is the creation of an industry-wide, bespoke system that will be used across much of the pharma supply chain to manage the FMD protocols. This would integrate with existing technologies within the production process, but would also extend to an end-to-end management of data to track and trace, identify counterfeits and provide a large amount of data at individual packet level until the drug is dispensed.

What may be reassuring to the pharmaceutical industry is that this scenario has already occurred within other industries, with complex and demanding protocols being handled with accessible costs and commercially attractive propositions, notably in the gas sector. All it takes is for one or two pioneering organisations to work with a software developer to design and build a system that automates and builds in the codes and requirements set down by the legislation. Critically, such a system must also be capable of adapting and changing to additional protocols as and when they are introduced. If desired, an upfront investment in development can be offset by a stake in the intellectual property as it is sold on to additional organisations, recouping a share of the revenue.

Next Steps

Often, when such a wealth of change is wielded upon a whole industry, a waiting game ensues for someone to make the first move. When a fully-formed solution is not laid out on the table, rather than fork out on a significant capital investment into an experimental new system, organisations wait for a tried-and-tested, affordable and pragmatic solution to enter the market. However, while manufacturers still have the luxury of time to determine a coherent strategy, investment is exactly what they should be looking at. Should any business within the supply chain fail to prepare for the 2017 deadline, they could find themselves, firstly, without an available technology or IT partner, and secondly, losing unimaginable amounts of revenue through lost trading days while playing catch-up. Manufacturers need to fully prepare now, and those that act first may benefit the most financially on a number of levels, not just strategically.

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Simon Slater is Managing Director of bespoke software development company, Datamere Software Solutions. Established in 1998, Datamere has pioneered and developed a number of industry-leading solutions to handle the complex protocols of various sectors, including gas, electricity, manufacturing and residential care. Simon also engineered an end-to-end automated smart metering service to remotely monitor energy usage at commercial sites. With a background in manufacturing, as well as developing a number of in-depth, credible industry systems, he has a proven track-record of solving complex logistical and procedural problems through expert programming.
Simon Slater
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