Massimo Crudeli
2023 was a record year for pharmaceutical product recalls. Learn how to minimize reputational damage and financial fallout in 2024.
Drug recalls are as bad for pharmaceutical companies as they are for patients—and unfortunately, they’re on the rise. At the end of last year, Contract Pharma announced that 2023 would be one for the drug recall record books. At the time of publication, Sedgwick’s Quarterly Recall Index Report had recorded 144 recalls in Q1, 135 in Q2, and 107 in Q3—all above the five-year industry average of 84.7 recalls per quarter.
What Are the Reasons for So Many Recalls?
As in previous years, sterility, cGMP deviations, and failed specifications due to impurities and product stability issues were the main reasons for drug recalls in 2023. But don’t forget about simple administrative mistakes. Things that don’t even impact product quality—such as improper labeling and incomplete certificates of analysis—can lead to recalls in the highly regulated pharmaceutical industry.
Your Recall Prevention Strategy Starts with a Modern ERP System
While the FDA encourages drug developers to be “recall ready,” a better strategy is to do whatever you can to avoid recalls in the first place. According to Chris Harvey, Senior Vice President of Brand Protection at Sedgwick, 30 of the 45 recalls related to sterility in Q3 2023 were attributed to a single company.
Pharmaceutical brands that want to avoid the financial fallout and reputational damage that can come from drug recalls should deploy a modern Enterprise Resource Planning (ERP) system for visibility into production processes. With a single source of truth for all your critical data—which continually updates in real time—your manufacturing teams will ensure greater control and consistency across the supply chain, in the plant, and in the warehouse.
The right ERP software, designed exclusively for pharmaceutical companies and other life sciences organizations, gives you the data-driven agility you need to identify potential issues at the source and take corrective action before products hit the shelves. The best ERP systems can help drug manufacturers prevent recalls by:
- Enabling complete and accurate traceability of raw materials and finished products
- Facilitating quality control, as well as product and process monitoring
- Helping ensure compliance with cGMP and other regulatory requirements
Many life sciences organizations are using outdated ERP systems.
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ERP Systems Can Minimize the Impact of Recalls, Too
If you have a product that must be recalled, an advanced ERP system can minimize the damage by helping you identify affected lots, the locations they were shipped to, and the customers who purchased them. Through the power of data integration, a comprehensive ERP solution combines your inventory information with your bills of materials and lading, batch tickets, lot numbers, storage locations, and more.
In a matter of moments, you can get a digital snapshot of the extent of your recall. This kind of comprehensive and timely visibility can prevent you from having to pull more products than necessary, can help you maintain trust and confidence with your consumers, and can make providing documentation to regulatory bodies much easier.
What to Look for in a Life Sciences ERP Solution
Pharmaceutical companies, biotech firms, medical device manufacturers, and other life sciences organizations should all look for ERP systems that are purpose-built for the industry. Key features related to supply chain management, quality management, and warehouse management are of the utmost importance.
STAEDEAN Is the Most Complete ERP Solution for Life Sciences
Convenient, configurable modules are purpose-built for life sciences organizations. These modules can be added as needed, making it easy to scale the solution so it grows with your specific needs.
STAEDEAN helps dozens of life sciences companies in the U.S., Europe, and Australia successfully start and complete their digital transformation journeys. Our plug-and-play ERP modules—built on the powerful and affordable Microsoft Dynamics 365 platform—are designed to easily automate workflows, collect relevant data in the correct formats, and conform to standards and regulations such as GMP, GAMP5, FDA 21 CFR Part 11, and EU Annex 11.
If you’re still using manual processes or legacy systems to manage your drug manufacturing operations, our solutions will make dramatic improvements that can improve your efficiency, lower your costs, and reduce the risk of the production downtime, legal and PR fees, penalties, and other costs associated with drug recalls.
Learn how STAEDEAN's purpose-built life sciences ERP solution can help your organization
Massimo Crudeli