The Importance of Track and Trace in The Pharmaceutical Industry

In the world of pharmaceutical manufacturing, transparency is key. Knowing the journey of medicines and vaccines from production to consumer is crucial. However, medicines change many hands before they reach the end user. This creates multiple opportunities for fake drugs to infiltrate the market.

Despite intricate supply chains, patents, and strict regulations, counterfeit drugs have been on the rise, especially post-COVID. According to the World Health Organization, counterfeit drugs cost the pharmaceutical industry close to $40 billion annually. Drug shortages, cost pressures, and online purchasing worsen the problem.

As a result, counterfeit drugs persistently drain finances, threaten pharma recalls, and severely impact brand reputations. In addition, the unmistakably heavy global health risk looms, creating an urgent need for robust track & trace systems.

Implementing these systems can help pharmaceutical companies monitor their supply chains efficiently. With track and trace tracking, regulators and authorities can weed out fake products, aiding consumer protection.

Hence, track & trace systems do not just ensure compliance in pharmaceutical production; they safeguard health in general. With this thought in mind, in the early 2000s, governments and pharmaceutical industry leaders joined forces to fight fake medicines and counterfeiting. Track & trace technology was adopted as a global standard to safeguard health and protect pharma manufacturing and healthcare brands.

Today, countries like those in the EU, the USA, and Russia have embraced serialisation and traceability regulations, following the GS1 standards. Read on to understand what is track and trace system in pharma, its importance and the many benefits it lends to businesses in pharmaceutical manufacturing.

What is Track and Trace in Pharma?

Track & trace in Pharma manufacturing is basically a set of procedures, records and systems, that allow manufacturers to securely monitor their products. These systems are installed from the production stage all through the distribution, and down to the pharmacy. This method plays a vital role in ensuring the safe delivery of pharmaceuticals to the consumers.

When a good track & trace system is in place, it allows companies to respond to recalls quickly and manage regulatory requirements promptly. This system is supported by serialisation in pharmaceutical production. This is a system of generating a unique identifying code for each pharma product and inserting the same on the individual product packaging before it is shipped. Different countries follow different serialisation methods. However, when followed consistently, serialisation enables easy and seamless tracking and authentication of a product whenever required.

Why is Track and Trace Important?

Today, more and more countries are following the pharma track & trace systems to increase transparency and fight counterfeits. However, for those still getting on board the journey is riddled with challenges, often due to multiple players and an exhaustive pharmaceutical industry.

For such countries, it is easy to engage experienced and trusted suppliers for implementation of track-and-trace technologies. Outsourcing the job helps ensure seamless compliance across the complex pharma manufacturing processes. It becomes easy to adhere to regulatory standards of bodies such as the Food and Drug Administration (FDA).

Track and trace systems also make documentation easy and simple through an automatic digital audit trail. This helps to reduce the burden of compliance for the manufacturers. Digital tracking also enables quick and timely identification of issues, especially during recalls. There is better detection of counterfeits, thus reducing the scope of waste and contamination.

Organisational Benefits of Track and Trace in Pharma:

There are numerous benefits of track and trace in pharma besides curbing the supply of substandard products and protecting consumer interest. Some of the most prominent benefits are highlighted as follows:

Enhanced quality management:

With track and trace tracking systems, there is complete visibility within the pharmaceutical manufacturing process. It helps manufacturers identify areas in production and supply chain that require more focus and improvement.

Tracking also helps managers identify the non-conforming products well in time and offer prompt resolution. As more and more data gets collected through tracking it is available for managers and manufacturers to access, compare and assess in real time. This aids problem solving and timely prevention.

Seamless regulatory compliance:

A digital track and trace system allows pharma manufacturers to automate their documentation seamlessly, enabling easy compliance with regulatory standards. It also facilitates the accuracy of record keeping and mitigates the risk of human error. With digital track & trace many companies have done away with manual record keeping.

Improved recall management:

Sometimes, product side effects result in recalls triggered by regulatory orders. In cases where the products have already been shipped, track & trace systems come to the rescue. They allow manufacturers to locate the shipment quickly and withdraw the products in a fast and efficient manner without confusion or chaos.

Conclusion

Today pharma manufacturing is incomplete without the trustworthy backing of the track & trace systems and solution providers. Pharmaceutical companies gain immensely through these digitized systems achieving regulatory compliance, operational efficiency and seamless supply chain management. Hence, digital tracking has truly transformed the landscape of pharmaceutical manufacturing.