The global pharmaceutical industry faces a plethora of challenges when it comes to drug labeling. Ever-changing Regulatory requirements, products that are no longer patentable, and market pricing pressures force the industry to aim for the competitive advantage through increased efficiency.

This article focuses on potential roadblocks in streamlining the labeling processes in the current situation as well as solutions to help companies better comprehend labeling considering these issues.

Here are four key labeling challenges that a company may face: 

Implementing new data integration processes

Data integration and its application is a significant step towards progress for pharma labeling. However, it is challenging. As this can be seen as a substantial impediment to achieving a single, unified picture of the data, drug companies need to integrate labeling with their Manufacturing Execution Software (MES) and Enterprise Resource Planning (ERP) systems.

An advanced label management system enables it to link labels with master data, digitize the entire label creation process, and empower business users to manage change requests. Pharmaceutical businesses can use this form of data integration to address a variety of label management challenges.

Compliance Issues

Under the drug labeling regulations such as the FDA CFR 21 part II, Eudralex Annex 11, and GAMP 5, companies must protect the electronic records’ security and accuracy. Because labeling is a necessary component of a quality management system, the Regulatory process is highly complicated. Also, pharmaceutical businesses must be audit-ready and meet the expectations of business partners and customers.

While a legacy approach to labeling causes a lot of manual overhead and paperwork, leveraging a single solution for a pharmaceutical company's labeling helps with Regulatory compliance by centralizing all essential data, making track and trace much easier.

Achieving Cost Reduction

With margins being squeezed across the pharmaceutical industry, cost containment has become a primary concern. Once the drug enters the manufacturing process, meeting Regulatory requirements increases the product’s market entry cost. Because of this, any procedure or technology that can eliminate the need for expensive IT resources and the duplication of efforts can reduce the cost for a faster return on investment.

Supply chain management

The pharmaceutical supply chain is highly complex and involves numerous steps, as ingredients are frequently shipped in bulk, repackaged, and reshipped before reaching the manufacturer of branded products.

Through modern labeling techniques, centralized labeling systems make the entire extended supply chain more responsive to the change requests and combat diversion and counterfeiting.

According to a survey conducted by a leading labeling service provider, 78% of pharma and biopharma companies do not have a modern, digital labeling solution in place, and 83% are looking for a new system that can reduce manual tasks and improve accuracy.

The above data highlights why should pharma companies worldwide realize the importance of improving their labeling processes and why they should adopt centralized, contemporary label management software.

If you would like to learn more and ensure submitting accurate eCTD submissions, reach out to Freyr a dedicated and established Regulatory software provider.


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