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 ...

Raw material verification is slowing pharmaceutical production, but mass spectrometry can offer a viable solution.

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 ...

The pharmaceutical industry faces stringent regulatory requirements to ensure the safety, efficacy, and quality of drug products. Among these, Current Good Manufacturing Practice (CGMP) guidelines set ...

FDA is anticipating how AI may advance manufacturing and improve supply chain security. Hollywood has long presented artificial intelligence (AI) as a futuristic concept far from reality, but ...

Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...

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 ...

Robust project management is essential in any manufacturing business, particularly where strict regulations and complex production processes require maximum alignment between all involved functions.

One of the trends that has emerged from the COVID-19 pandemic is the onshoring of U.S. pharmaceutical manufacturing. As more companies focus on manufacturing in the U.S., they face stringent ...

West Pharmaceutical Services strengthened its position in the healthcare supply chain as demand for injectable drug solutions ...

Key opportunities in the pharmaceutical manufacturing software market include leveraging AI and ML integration, cloud adoption, and expansion of smart manufacturing facilities. There's potential in ...