Advancing Pharmaceutical Traceability: Top 10 Traceability Essentials and How EDI Can Help


October 27, 2023

The pharmaceutical industry is a highly regulated sector with stringent government standards and requirements to ensure drug safety and quality. Manufacturers in this industry must comply with various traceability, serialization, and quality control regulations. In this blog, we’ll explore why manufacturers in the pharmaceutical industry need traceability and how Electronic Data Interchange (EDI) plays a vital role in the process.  

Why Pharmaceutical Manufacturers Need Traceability  

Traceability refers to tracking an item, materials, parts, or products throughout the manufacturing process and the supply chain. Items can be traced at the individual, batch, lot, or shipment level. 

Traceability is a fundamental necessity for pharmaceutical manufacturers, serving a multitude of critical purposes. It guarantees adherence to regulatory requirements, upholds the integrity of product safety and quality, mitigates risks, safeguards brand reputation, enhances transparency, and streamlines supply chain operations. Let’s take a look at the top ten reasons pharmaceutical manufacturers require traceability and how EDI can help meet those needs. 

1. Regulatory Compliance  

The pharmaceutical industry is subject to extensive regulations, including Good Manufacturing Practices (GMP) and the Drug Supply Chain Security Act (DSCSA) in the United States. Traceability helps manufacturers adhere to these regulations by implementing systems that track product movement and status throughout the supply chain. 

EDI systems provide manufacturers with an added layer of regulatory compliance support by automatically generating compliance reports—simplifying the reporting process and reducing administrative burdens associated with compliance. 

2. Product Authentication 

Counterfeit pharmaceuticals pose a significant risk to public health. Traceability enables manufacturers to verify the authenticity of their products at various points in the supply chain, reducing the risk of counterfeit drugs entering the market.  

EDI further enhances traceability by relying on standardized data formats and protocols. This standardization simplifies data interpretation and ensures consistent traceability of information throughout the supply chain, contributing to the overall effort to mitigate the risks associated with counterfeit drugs. 

3. Recall Management 

In the event of a product recall, traceability helps manufacturers quickly and accurately identify affected batches. This minimizes the impact on patients and allows for efficient removal and replacement of affected products.  

In the event of a recall, speed and accuracy are paramount. EDI streamlines this entire process by facilitating rapid and accurate communication, providing real-time data and automating critical processes. 

4. Supply Chain Visibility 

Traceability provides real-time visibility into pharmaceutical product movement and status. This visibility enables manufacturers to optimize their supply chain, reduce lead times, and improve inventory management.  

EDI takes this a step further by delivering up-to-the-minute details on product movement and status, delivering the real-time visibility and timely information that’s required for effective decision-making. 

5. Quality Control  

When your business and the well-being of your customers rely on product information being precise and accurate, you can’t afford to make mistakes. Traceability assists manufacturers in monitoring and tracking key quality metrics throughout the production process. Early detection of quality issues facilitates corrective actions to maintain product quality and safety. 

EDI eliminates manual data entry and paper-based documentation that produce these metrics, reducing the risk of errors and ensuring reliable tracking and traceability of records. 

6. Efficient Serialization 

Many countries require serialized unique identifiers on pharmaceutical packaging to track individual product units. Traceability helps manufacturers implement serialization processes to ensure compliance. 

EDI systems are key in this process, as they generate and exchange serial numbers and related data to comply with serialization requirements, ensuring each product can be traced back to its origin. 

7. Data Management 

Traceability helps companies collect and store vast amounts of data related to product movement and status. It also offers tools for efficient data management, analysis, and reporting, assisting manufacturers to make data-driven decisions and improve operational efficiency.  

EDI takes data management a step further by enabling real-time data exchange among stakeholders in the pharmaceutical supply chain. This facilitates immediate tracking and traceability of pharmaceutical products as they move through the supply chain. 

To ensure confidentiality and integrity of data, EDI systems employ robust security measures, including data encryption and cybersecurity that meet SOC-2 compliance standards.   

8. Supply Chain Collaboration 

Traceability facilitates data sharing and collaboration among various supply chain stakeholders, enhancing overall efficiency and visibility.  

EDI automates communication between supply chain partners, allowing quick sharing of critical traceability-related information. TrueCommerce customer, Med Test, was able to streamline information exchanges with their distributors when they leveraged TrueCommerce trading partner connectivity. 

9. Global Expansion 

As pharmaceutical companies expand globally, traceability helps them navigate complex international regulatory requirements and maintain compliance in various markets. By implementing robust traceability systems, companies can effectively monitor the movement, status, and authenticity of their products as they traverse various regions and jurisdictions. These systems provide the necessary transparency and control that are vital for ensuring that pharmaceutical products meet the stringent quality and safety standards imposed by different regulatory authorities worldwide. 

 By seamlessly integrating with traceability systems and databases, EDI ensures that all relevant data, such as batch numbers, production records, and shipping information, is readily available for traceability purposes across regions. 

10. Brand Protection 

Protecting a pharmaceutical brand’s reputation is paramount. Traceability reduces the risk of counterfeit products, ensures product quality, and responds quickly to issues to maintain brand integrity.  

By utilizing all these powerful aspects of EDI to meet traceability requirements and improve the pharmaceutical supply chain process, manufacturers are able to maintain a positive brand reputation that will enable them to expand supplier relationships and grow their business. 

Harness the Power of EDI for Traceability 

By definition, EDI simplifies business processes by replacing manual data entry such as mail, fax, and e-mail with electronic exchanges of business documents between two companies that may use vastly different internal business systems. Because of its data-centric nature, EDI plays a vital role in supporting traceability in the pharmaceutical industry.  

Traceability and EDI are integral to ensuring compliance with regulations, maintaining product quality and safety, protecting pharmaceutical brands, and optimizing supply chain operations in the pharmaceutical industry. These solutions provide the technology, expertise, and infrastructure needed to navigate the complex regulatory landscape and supply chain challenges while enhancing traceability capabilities.  

The TrueCommerce globally recognized EDI solution is a fully managed service trusted by thousands of manufacturers, retailers, suppliers, distributors, and other trading partners in the pharmaceutical industry. To see how TrueCommerce EDI can help you protect your supply chain during a recession and accelerate key business processes, request a free demo today

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