Given the critical nature of medicines, vaccines, and other pharmaceutical products, it’s important for consumers and regulators to have a clear understanding of where the product has been, what’s gone into it, who was involved in its production, as well as many other details about its journey through the supply chain.

This is especially important given the increase in counterfeit pharmaceuticals identified in the global drug supply chain following the Covid-19 pandemic. Without effective track and trace procedures in place, it would be increasingly difficult for government and regulatory agencies to identify and eliminate these counterfeit products from reaching consumers.

In order to prevent illegitimate products from entering the market, as well as simplify recalls for defective products should the need arise, businesses and industry regulators rely heavily on a combination of traceability systems and compliance records to track the details associated with affected pharmaceutical batches.

In this post, we’ll discuss the importance of pharmaceutical track and trace systems and how manufacturers are able to streamline their traceability procedures and simplify compliance.

What is track and trace in pharma?

Pharmaceutical track and trace is a combination of records, systems, and processes that enable manufacturers to ensure that their products are securely tracked from the manufacturing plant, through distribution, and onto the pharmacy shelf. This process is critical for the safe and effective distribution of pharmaceutical products to consumers.

By having a good track and trace system in place, companies can quickly respond to any recalls or outbreaks and ensure the products they are providing meet all necessary regulations.

Track and trace in pharma manufacturing is supported by serialization – the generation of a unique identifier for pharma products and inclusion of the code on the label or packaging before items are shipped.

An effective, consistent serialization process allows for tracking, tracing, and authentication of pharma products at any given moment.

The importance of pharma track and trace systems

Due to the complexity of pharma manufacturing processes, regulatory bodies like the Food and Drug Administration (FDA) need manufacturers to label, track, and document each object along the supply chain and throughout its life in the market.

Track and trace systems help manufacturers simplify the documentation of materials, personnel, and processes involved in production, automatically creating a digital audit trail, and reducing the burden of regulatory compliance for manufacturers.

Using digital systems to track a drug from production to distribution helps to identify any issues, such as product recalls, in a timely manner. It also helps to detect counterfeits, reduce the risk of contamination, and minimize waste.

Organizational benefits of pharma track and trace

Apart from preventing substandard items from entering the supply chain and protecting consumer health, track and trace systems provide a number of business benefits to manufacturers. These can include:

Improved quality management: Pharma track and trace systems provide comprehensive visibility into the manufacturing process. As a result, manufacturers can identify production and supply chain sections that require improvement.

Tracking items as they progress through production ensures that quality officers identify nonconforming events in time for efficient resolution. Collecting and accessing data in real-time allows manufacturers to identify and solve the root cause of problems, preventing reoccurrence.

Simplified compliance with regulatory requirements: Regulators require significant, thorough documentation of every aspect of the pharmaceutical production process. By having a digital track and trace system in place, pharmaceutical manufacturers can automate data collection and digitize documentation. This helps to eliminate the need for manual record-keeping and reduces the risk of mistakes and inaccuracies resulting from human error.

Efficient recall management: In some instances, regulators might determine that a company’s pharma products cause adverse consumer effects. As a result, regulatory bodies will order the manufacturer to recall products already shipped.

Having a robust track and trace system allows manufacturers to withdraw all affected products from distribution as quickly and efficiently as possible.

Tips for implementing pharma track and trace systems

When implementing a track and trace software system for a pharmaceutical company, there are several key considerations to take into account. Some of the key considerations include:

  1. Evaluate your company’s specific needs and challenges. Consider what data needs to be tracked, as well as how it needs to be processed and stored.

  2. Keep security in mind. Given the sensitive nature of pharma production data, it’s important to select a software provider that offers a secure, reliable system that meets your needs. Additionally, it’s important to ensure that the software you choose is compliant with all relevant standards and regulations.

  3. Consider your existing tech stack. When implementing a track and trace system, make sure the software you choose can integrate with the other systems used across your operations.

  4. Communicate changes with your entire team. Whenever you’re implementing any new system or technology, communication is critical to ensure everyone can adapt to any changes in process. Additionally, training your workforce on the new software will help to ensure a seamless rollout.

How Tulip helps pharmaceutical manufacturers improve their track and trace capabilities

Tulip’s platform is used by some of the largest pharmaceutical manufacturers to automate data collection and streamline compliance activities from manufacturing to distribution.

Tulip’s ability to integrate with existing systems such as ERP and MES allows manufacturers to track products as they move through the production process and visualize data in real time. Tulip’s advanced analytics help manufacturers identify potential issues across their processes including bottlenecks or quality control issues.

Leveraging our digital work instructions app, manufacturers are able to incorporate inline quality and compliance checks to ensure products are properly labeled and tracked throughout the supply chain. This helps manufacturers avoid costly fines and penalties for non-compliance.

If you’re interested in learning how Tulip can help improve your track and trace capabilities, reach out to a member of our team today!

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