Process development is the exercise of creating new and improved manufacturing methods, optimizing them in terms of time and financial efficiency while maintaining regulatory compliance and product ...

Additive manufacturing allows pharma and biotech companies to take advantage of 3D printing technology to produce medications ...

What is Real-Time Release Testing? Real-Time Release Testing (RTRT) is an advanced approach to biopharmaceutical manufacturing quality control that improves upon current systems. RTRT is defined as ...

In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, ...

Eli Lilly’s breast cancer med Verzenio may look like your standard drug tablet—ovular, off-white, emblazoned with the dosage on the front and Lilly’s logo on the reverse—but behind that modest façade ...

Company to Showcase Integration of AI, Digital Batch Records, and Intelligent Robotics to Accelerate Pharmaceutical ManufacturingAGOURA HILLS, ...

The compliance process at pharmaceutical manufacturers is complicated because many still use paper-based systems to record manufacturing steps. These paper records are reviewed by FDA auditors to ...

Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based manufacturer. NRx has completed confirmatory GMP audits of ...

Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug ...

The breakthrough positions the specialty chemicals manufacturer at the forefront of advanced fluorination technologies, ...