Ireland: This Process Is Meant to Verify That the Medicine Meets Safety and Potency Requirements

Sanofi is facing shortages of two Pompe disease treatments, Myozyme and Nexviazyme, after the U.S. Food and Drug Administration warned the company about manufacturing issues at its facility in Waterford, Ireland. The drugmaker has alerted patient groups and physicians in the U.S. and Europe that supplies are dwindling due to a bottleneck in the final manufacturing phase and quality control problems at the plant. The site handles batch release, the final quality assurance and regulatory step where a manufactured batch is certified, approved, and cleared for distribution. This process is meant to verify that the medicine meets safety and potency requirements.