The study makes clear that regulators expect human oversight to remain central to pharmaceutical quality assurance. Human operators must participate at key control points and retain authority to ...

When patients are prescribed complex therapies — like specialty drugs, cell and gene treatments, or high-cost biologics — the path to treatment is rarely straightforward. Filling a prescription can ...

Biopharma quality control is being revolutionized by advanced analytics and digital transformation through a synergy that boosts quality and scalability. Digital transformation and advanced analytics ...

A pharmaceutical company upgraded its lyophilizer to integrate with a centralized SCADA system, enabling unified reporting, centralized user management and easier maintenance across all plant ...