Implementation of automation technology that address Serialisation requirements for the authentication of drugs can also provide the foundation for improved production, supply chain and QA efficiencies – offsetting the costs, argues Dean Chespy, Life Sciences development manager, Siemens Industry Automation
The failure of any pharmaceutical manufacturing business to demonstrate that it is doing all it reasonably can to secure and authenticate its products could fatally damage its brand and reputation. Businesses cannot risk a situation where lives are at stake and they have failed to implement measures that would support the kind of ‘track and trace’ product strategies regulatory authorities around the world are beginning to insist upon.
The World Health Organisation (WHO) estimates that up to 1% of medicines available in developed countries are likely to be counterfeit and the worldwide trade in counterfeit drugs currently accounts for 5% of all drugs sold. While in previous times it was thought the problem was purely limited to developing countries, there is now clear evidence that it has become a more commonplace issue in so-called developed economies as well.
The explosion in the popularity of internet-based ‘pharmacies’ is exposing patients – who are attracted by competitive product prices found on the web – to potential inherent risks as such a distribution channel cannot offer the product traceability and quality reassurance found via traditional dispensing channels. The WHO estimates that potentially 50% of medicines available from internet sites which conceal their physical address may be counterfeit. In addition, some counterfeit medicines discovered in the UK have been found to contain a reduced amount of the active pharmaceutical ingredient which creates concerns both in terms of safety, as well as value for money for the consumer using such means to access medicines.
product serialisation
In a world where the online trade of fake drugs is all too visible, where there is a growing incidence of fake products reaching licensed distributors and pharmacies through product diversion, and where a large proportion of counterfeit medicine seizures are of ‘commercial size’, pharmaceutical manufacturers need to be sure they are doing all they can to secure their supply chains and prove product authenticity.
Against this backdrop, various regulatory bodies have sought to increase levels of security to underpin all aspects of patient safety and, crucially, product traceability. Regulators are laying down ever-stricter rules governing drug manufacture with product serialisation at its centre. Current legislation ranges from the FDA model in the US, which has developed a standardised numerical identifier, through to the European Federation of Pharmaceutical Industries and Associations (EFPIA), which is adopting a unique coding solution to perform product authentification at the point of dispensing. Other regionally-based legislation requirements, in place in countries such as Turkey and France and the US, only increase the wave of regulatory scrutiny that is sweeping across the pharmaceutical industry.
It provides more complexity for companies trying to manage a worldwide supply chain. As the battle to tackle the counterfeit threat on many fronts continues, the industry needs to ensure that it continues to offer and develop a rigorous defence of its manufacturing methods, product visibility and product traceability. Not only will this help in the fight to expose counterfeit products whenever they appear in the supply chain, but it also ensures that businesses are protected when it comes to ensuring their processes and products can satisfy any current or future legislative requirements.
The ability to prove the authenticity of product will continue to be a crucial business issue for all manufacturing companies as the levels of regulatory control are enhanced in regional, national and international markets. The industry also relies upon the production of reliable and accurate data as a central platform of its manufacturing processes and ongoing product security.
To meet both objectives, they need to examine some of the real benefits to be derived from a strategic automation technology solution which can range from the widely used track and trace benefits of radio frequency identification (RFID) technology through to newer concepts such as Serialisation and ‘ePedigree’ as the latest steps forward to help companies improve both their operational processes and market traceability.
Automation technology not only provides the gateway to enhanced operational efficiencies in the manufacturing process, it will also provide the support mechanism to help companies meet their legal obligations for product transparency and traceability, ensure true product identification across the entire product lifecycle and, thus, help to minimise the risk of counterfeiting.
At its broadest level automation technology solutions help link shop floor manufacturing to the boardroom via automated control and data acquisition levels. It generates and delivers the information and performance infrastructure that underpins product manufacture transparency and traceability, as well as help companies focus upon operational efficiency as a key business driver within an increasingly competitive marketplace.
While the benefits of solutions such as RFID are widely understood and implemented, the drive to increase the standards of product security for pharma companies has led to the growth and adoption of the concept of Serialisation. As globalisation across the industry increases, so too does the complexity of the supply chain, posing new challenges and, potentially, bringing new levels of vulnerability to companies that develop, manufacture, distribute and dispense drugs.
supply chain security
Serialisation is a process of identifying an object with a unique serial number that can be exchanged universally and it lies at the heart of supply chain security. Within the pharmaceutical industry it can be applied to each item, case and pallet of a drug to authenticate the individual product and enable tracking and tracing (and building a pedigree) within the supply chain of manufacturers, distributors and wholesalers. Specific preference can be catered for so that identification technology such as data matrix, bar code, line code or RFID can be utilised so that it marries with existing machinery and legacy technology.
However, the benefits of Serialisation go beyond just the supply chain security. Through Serialisation it is not only possible to uniquely identify an object and to track its movement across the supply chain to point of sale, it is also feasible to assign attributes to an object such as location and timestamps (for track and trace), temperature, humidity and all quality attributes such as production and process data – which would not be available on any counterfeit medicine. Once this data is collected and assigned to the object, companies can respond to and manage the associated product information.
The specific objectives of Serialisation depend on the application, and in the pharmaceutical industry such goals may be to check the authenticity of a product, prevent counterfeit products from entering the supply chain, improve product recall management, or even aid a complex investigation in a case of an adverse event or incident. Indeed, it can also be utilised to support an organisation in other ways, for example helping to manage the performance of rework activities, in-line or off-line, provide ‘pick-and-pack’ process warehouse support, enable promotion management activity or assist in tracking returnable transport items.
Serialisation can be further enhanced through implementation of an ‘ePedigree’ solution which sees a product adopt an electronic record of information that is authenticated and updated electronically as it moves along the supply chain.
improving efficiencies
As important as tackling the counterfeit drug issue, Serialisation also provides a solid foundation for a business system framework to help drive future production and supply chain efficiencies, asset utilisation, quality and other supply chain measures to higher levels of performance.
Going forward it is clear that legislative requirements on drug producing companies will become even more stringent. It is believed that there is a real potential for mandatory measures such as drug authenticity (relating to its original certified manufacturing data) and electronic pedigree (a record documenting that the drug was manufactured and distributed under secure conditions) being implemented either in the US or on a global scale. It is certain that pharmaceutical businesses will have to comply with such rules if they are to continue developing, manufacturing and selling their products in large parts of the worldwide market.
Compliance with such requirements to counteract the drug counterfeit market requires effort and investment. With the pharmaceutical industry facing increased pressures regarding time-to-market, market responsiveness, cost reduction and manufacturing flexibility, automation technology solutions such as Serialisation help satisfy the need for transparent information, business process improvements, product safety criteria and overall supply chain efficiencies and security.
