There’s no shortage of rules and regulations in the pharmaceutical industry. The U.S. Food and Drug Administration (FDA), for example has guidelines—and mandates—around manufacturing processes, quality control, testing and record traceability for each batch. And, they’ve put the responsibility on pharma teams inside each organization to make sure all critical processes are validated for consistency and compliance. The problem, however, is that many of the systems on the plant floor are not fully integrated, making it difficult to deliver on many of the goals outlined by the FDA.
Having to engineer and synchronize data between systems adds additional work, that, while keeping quality in-check, could impact time-to-market. But ABB and Werum IT Solutions, recently rolled out a connected system that could help alleviate integration issues. The software module is the result of a partnership that the duo announced two years ago, in which ABB and Werum agreed to collaborate on a long-term roadmap to align their offerings, thereby simplifying operations for pharmaceutical and biotech customers.
The software module integrates Werum MES PAS-X manufacturing execution system (MES), developed in strict accordance with legal requirements such as FDA 21 CFR Part 211 and Part 11, EU GMP and GAMP 5 guidelines, with ABB’s Ability System 800xA Batch Management. The offering includes features for automatic parameter assignment and automatic synchronization of recipe procedures with the MES.
The module, first unveiled at the Werum IT Solution’s annual user group meeting in October, has been implemented at GE Healthcare’s manufacturing facility in Uppsala, Sweden, which is one of the world’s largest installed capacities for the production of chromatographic resins. Now, the integrated offering, dubbed the “Shop Floor Integration Solution for Life Sciences,” is available globally. By deploying the software, companies will experience faster master batch record (MBR) creation and simplified operations through “plug-and-produce” integration that conforms to good manufacturing practices (GMP), the companies said.