One of the oldest in the world, the pharmaceutical industry has had to face many challenges over the years. One of the biggest challenges that still presents itself today is how to address batch traceability when it comes to pharmaceutical manufacturing.
The importance of Pharma batch traceability
For a multitude of reasons, pharmaceutical manufacturers need the ability to maintain traceability throughout their entire batch process. This means being able to identify every single ingredient and process step that was involved in creating a production batch. When an issue arises, this information can help determine which step caused the problem and where it may have originated.
Batch traceability will not only help identify what went wrong, but also provide critical data for addressing any resulting challenges. A manufacturer should be able to provide an audit trail for every batch manufactured, as well as being able to easily retrieve this information when needed.
When combined with other quality systems such as an SOP manual or cGMP guidelines, batch traceability becomes more powerful than ever before.
DSCSA (Drug Supply Chain Security Act)
Brought to life by the FDA and Congress in 2013, the DSCSA was designed to change the way pharmaceutical products and raw materials are treated throughout the supply chain, including prescribed ways to trace the movement of products when packaged and distributed. The goal of the DSCSA was to increase security pharmaceutical products and safety for patients using pharmaceutical finished goods. This then new law offered:
- 1 Single federally supported solution to replace requirements that might have been different for every state
- A simplified, consolidated view of supply chain regulations that focus on enhanced patient safety and security
- Higher standards for distributors in the U.S.
- Streamlined processes for identifying suspect or counterfeit goods in the supply chain
As we approach the 10-year deadline set by the DSCSA, where partners in the supply chain will need to provide item-level traceability when products move from one party to another, it’s critical for stakeholders to make sure they’re in full compliance.
The longer you go without implementing a track and trace solution, the more at risk you are to face things like heavy fines, loss of licensure and even imprisonment.
For more information about the act – see https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa
GS1 traceability standards
With so much more data getting captured every second, GS1 standards are a way to focus on what’s important – with a set way to manage your supply chain data to make sure important data is always available, understandable and 100% accurate.
GS1 traceability standards are part of a larger global framework used in over 100 countries to make sure the systems they use for traceability are designed for interoperable collaboration and sharing information for the entire supply chain using the following.
- Critical Tracking Events (CTEs) Actual events that occur throughout the lifecycle of a traceable product or raw material. This includes things like packing, shipping, and receiving.
- Key Data Elements (KDEs) Important information and data regarding the specific pieces of Critical Tracking Events.
- Global Trade Item Numbers (GTINs) and Global Location Numbers (GLNs) Unique identifiers for finished goods and raw materials as they move through the supply chain.
According to GS1, there are four key events that should be given the most attention as finished goods and raw materials move through the supply chain:
- 1.What product(s) were impacted?
- 2.When did the event occur?
- 3.Where did the product(s) come from? Where are they now?
- 4.Why was this process observed?
For more information about GS1 traceability standards – see https://www.gs1us.org/industries-and-insights/by-industry/healthcare/standards-in-use/pharmaceutical
Pillars of batch traceability
Figure 1:Pillars of Batch Traceability
With the law already written, it’s up to partners to figure out how they’ll meet the requirements. In order to make sure this compliance can be met there are four underlying pillars of batch traceability that should be implemented one way or another.
- 1.Serialization – The ability to create unique identifiers for a product that might have multiple packaging options. This typically includes things like serial numbers, lot numbers and expiration dates.
- 2.Track and trace – Like Serialization, track and trace is all about where a product has been and where it is now. This helps highlight any changes of ownership, determining the original manufacturer, or tracking all movement throughout the supply chain, even if it hasn’t changed ownership.
- 3.Verification – The ability to verify the details about where a product is or has been in the supply chain. This includes requirements to confirm specifics like serial and lot number, movement and transaction history, and more.
- 4.Reporting – The ability to report accurate information about serialization, track and trace, and verification to regulatory bodies as needed and required.
The ability to report accurate information about serialization, track and trace, and verification to regulatory bodies as needed and required.
These pillars are designed to work together to give you a more detailed view of the products in your supply chain, and lets you share that data with your partners, customers and more.
Batch and item traceability doesn’t just help protect consumers from harm – it also keeps your company in compliance with regulatory bodies like the FDA. Batch traceability software lets manufacturers and distributors alike easily track every batch of product manufactured during a certain timeframe.
All said and done, a properly implemented track and trace solution will allow you to fully trace finished goods and raw materials as they move through your supply chain from start to finish. Being able to track your products helps to prevent theft and counterfeit copies and makes sure your products remain safe for use. Being able to trace your products lets you closely follow and monitor every product in your supply chain leading to fast, efficient returns and recalls, confidence in your products, protection of your brand, and more. A solution like Microsoft Dynamics 365 makes this all possible by providing a customizable system that can be tailored to your specific business needs.
After 2023, track and trace won’t even be an option – this will be a requirement if you want to keep doing business in the pharmaceutical industry. The sooner you have a system in place the better.
Not sure where to begin? Contact us today to see how we can help.
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