Pharmaceutical serialisation: It’s more than meets the eye

Siddhant Bhambhani, Product Manager, ACG Inspection Systems, highlights about the benefits of serialisation other than mere regulatory compliance and also proposes few directions for efficient implementation of serialisation

Counterfeiting of medications is a major problem faced by the global pharmaceutical industry. As per WHO estimates around 30 per cent of the medicines sold in developing countries are counterfeit.i Owing to globalisation, the supply chain for medicines has become lengthier with every step offering another opportunity for counterfeiters. As a result, global track and trace requirements have become stringent putting tremendous pressure on the supply chain’s transparency. Pharma companies do believe that counterfeiting can be reduced significantly by implementing product serialisation. Serialisation requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Therefore, serialisation is often looked upon as an effort and cost-intensive process and often a regulatory mandate.

Serialisation: Looking beyond regulatory compliance

Using serialisation as a business strategy

Serialisation projects are primarily driven by regulatory compliance. However, pharma companies can unlock additional value if they implement the serialisation projects with a holistic view and considering serialisation as a business strategy as against compliance need. Pharma companies are now increasingly adopting a strategic business view for overall adoption of serialisation. They have started developing packaging and information technology to not only ensure regulatory compliance, but also use this for their own business gain: safeguarding brand reputation and ensuring patient safety to name a few. Serialisation and traceability can also be used for effective management of supply chain and management of medicine inventory at wholesale and retail levels.

• Protecting brand reputation: Counterfeit drugs pose a huge risk to pharma companies. It not only affects potential sales, but also leads to deterioration of brand reputation and brand value. Brand reputation is of utmost importance for the pharma industry, as compromised drugs can potentially harm the patients’ health. Therefore, serialisation and traceability allows pharma companies curb counterfeiting and protect the brand image.
• Improved processes: Serialisation and traceability can standardise and harmonise operational processes in across manufacturing units, warehouses and distribution hubs, resulting in smooth operations.
  It also assists in scanning and removing expired, faulty or damaged product ensuring that only genuine product reaches the consumer. Further, it helps manufacturer by preventing revenue loss occurring due to recall of faulty or damaged product. Track and trace system can help in finding the exact reason for the damage of the drug.
• Ensures better control over parallel trading: Parallel trading is when goods are bought in low price and sold in the market when their price increases. This is considered as an illegal process in certain industries where the cost of the product is a cumulative of the actual cost and additional import and export taxes. Track and trace is quite useful to curb parallel trading.

Serialisation is a cost-saving exercise

Serialisation and track and trace projects are often perceived as a process that leads to loss of revenue. This loss is majorly due to loss of time due to complex serialisation framework and equipment handling. Often pharma companies do not consider the upside to implementation of serialisation projects. Currently, the global counterfeit drug market allegedly makes for approximately $200 billion. Successful implementation of the serialisation projects can help curtail the problem of counterfeiting saving restoring the revenue lost due to counterfeit medicines.

Serialisation also helps eliminate manual errors, such as incorrect entry of GTIN or batch numbers (prevalent in manually operated machines), that are linked with loss of productivity. Furthermore, loss of time due to human intervention adds to the loss of production and subsequently revenue. Automation in the serialisation machines can minimise the loss of productivity; however, these machines are expensive.

Four directives for effective implementation of serialisation

• Use master data management effectively: In the pharma industry, data pertaining products, such as APIs, the production facility, product packaging or product market information is managed inconsistently without a proper structure. This is because data management entails substantial data governance and project management hurdles. However, the scenario is changing with pharma companies embracing Master Data Management (MDM) by investing in data harmonisation and analysis solutions after realising the myriad benefits including business and customer relationship benefits.
  It is important to integrate serialisation in master data management. Data pertaining to serialisation enables product authentication for trading partners, dispensers and government agencies. However, most companies disregard fundamental aspect of MDM laying emphasis at only on applying serial number to the products and then on transactional data. However, it is important to apply efforts beyond just getting a number on a package and set up a structured and clearly-managed master data.
• Understand that serialisation is a cross-functional endeavour: The process of serialisation is not (and should) be restricted to a particular department. Adoption and effective implementation of serialisation involves strategic integration of various departments, primarily the packaging, quality control, distribution and IT departments. For example, serialisation necessitates packaging team and IT to communicate in a bi-directional. As discussed earlier, serialisation creates value beyond regulatory drivers. Therefore, effective cross-functional efforts during strategy, planning, deployment and operation stages can ensure efficient and cost-effective implementation of serialisation.
• Understand cross country serialisation regulations to be global ready: Understanding cross country regulations for serialisation, track and trace is very important for the pharma companies to be global ready. Countries across the globe are defining their own regulations for serialisation, track and trace. However, currently there are no globally standardised regulations. As a result, pharma companies have to comply with different regional regulations to export their products. For instance, the US does not mandate parent child aggregation under its norms, whereas, the upcoming European regulations do. To bridge this gap, and to facilitate export of the pharma products, it is of paramount importance for the pharma companies to be well versed with the local as well as regional regulations. Accordingly, pharma companies must adapt their IT infrastructure, production levels, packaging lines solutions and business processes.
  Consulting companies provide traceability solutions through track and trace systems and applications. This is to ensure pharma companies are compliant to key compliance requirements such as 21 CFR Part 11, GMP etc.
• Select the right partner: Adopting serialisation is a highly complex process. Selecting a right partner plays a critical role in the success of serialisation projects. Different countries have different requirements for serialisation based on the regional needs. Furthermore, track and trace and defining parent-child relationship is also mandated in some countries like India, Turkey and South Korea. This generates a need for a partner that specialises in that region for implementation of serialisation. To cope up with this, companies have started providing multi-country, multi-language solutions in serialisation. It is important for pharma companies to select serialisation partner prudently based on its expertise in cross country regulations at various levels of packaging.

Conclusion

Serialisation and traceability is a complex process. However, an efficiently implemented serialisation and traceability processes can offer benefits that are beyond regulatory compliance such as patient safety, safeguarding brand equity and reduce revenue loss. Diligent data management and an integrated approach to serialisation can help in proper implementation. However, there are companies who have experience in both pharma and inspection technologies that can smoothen the process and ensure cross-country regulatory compliance. It is essential for particular pharma companies to partner with trusted and experienced solutions provider to achieve successful serialisation and traceability.