pharmaceutical serialization compliance

Pharmaceutical serialization compliance will soon be a reality for every pharmaceutical manufacturer. Regulations are already in place in China, Turkey, South Korea and India to name a few markets, and with the U.S. and the EU soon to follow, time is of the essence. In our final blog in the series, serialization director Carlos Machado and our senior R&D product manager Matteo Barbieri, discuss the inevitability and importance of serialization, highlighting the need to establish best practice and the advantages of standardization, flexibility and scalability to achieve short and long-term business benefits.

The pharmaceutical industry is faced with the growing challenge of counterfeit medicines throughout the supply chain. The World Health Organization (WHO) has estimated that between seven and 15 per cent of all medicines circulated in developed countries are falsified, while the figure is closer to 30 per cent in developing countries. New serialization regulations have been introduced to help tackle the issue and guarantee patient safety. Failing to achieve compliance will not only have a negative impact on business reputation and competitiveness, but it will also prevent the supply of vital medicines to patients. As a result, the successful rollout of a serialization solution is of paramount importance.

Best practice

Pharmaceutical serialization and drug traceability guidelines are present in more than 40 countries worldwide, however with no standardized approach, manufacturers are presented with a complex web of technical, regulatory and operational challenges. While the DSCSA and EU FMD guidelines are yet to enter into force, it is possible to learn from countries that already have successful programs in place.

For example, Turkey introduced its track and trace system in 2010 to tackle pharmaceutical reimbursement fraud and has adapted well to the new serialization requirements, which now require a 2D data matrix to be verified before gaining reimbursement. The process has revealed the need to build flexibility around installation and validation, and the importance of developing new standard operating procedures (SOPs) to make internal processes more efficient.

Aim for standardization

Pharmaceutical serialization compliance will have an impact across an entire organization, including across sites and geographies. Consequently, it is important that standardized processes are put in place that can maximise effectiveness, helping with the swift rollout of new systems and technologies at different sites and ensuring a model for best practice. As part of this, ensuring that staff have an understanding of their role in achieving pharmaceutical serialization compliance will be key and investing in on-going training will help to overcome potential technical, logistical and regulatory issues that could prove to be detrimental to business performance.

Future proof with flexibility

Regulations are likely to evolve and new requirements introduced across the multiple geographies in which manufacturers operate. Accounting for the future will be critical to business success, therefore identifying a flexible and scalable solution from the outset will maximize the chances of success. Implementing technologies and processes that can cater for individual market requirements, such as aggregation, can also help to save time and money. For those companies that do take a long-term view, it is possible to maximize the return on investment by identifying ways to refine and improve business operations that can bring wider benefits.

We hope that you have found our serialization series useful, in case you missed any you can find a full list of blogs below:

Opportunity knocks: drug serialization in Europe and the US

Safety first: drivers of serialization

Beyond compliance: serialization across the globe

Ahead of the curve: planning for serialization

Joined up thinking: Serialization in practice

If you would like to find out more about implementing serialization, including selecting the right partner, download our free e-book or you can download our serialization for late starters e-book here. If you would like to discover how we can help you on your serialization journey, contact us today.