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 ...

Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

AI is already helping the biopharmaceutical industry to optimize its manufacturing activities, according to IFPMA.

DÜSSELDORF, Germany & TOKYO--(BUSINESS WIRE)--Asahi Kasei has developed a novel membrane system for dehydrating organic solvents for pharmaceutical applications without the application of heat or ...

SK pharmteco announced today that it will host Innovations in Pharmaceutical Manufacturing: Continuous Manufacturing, Advanced Processing & Scalable Technologies, a premier one-day scientific ...

Regulatory pressure from GxP, 21 CFR Part 11, and AI/ML guidance elevates requirements for audit trails, data lineage, ...

A closer look at how robotics is reshaping pharmaceutical manufacturing, from improving quality and compliance to enabling ...

Visit NAP.edu/10766 to get more information about this book, to buy it in print, or to download it as a free PDF. In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical ...

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 ...

DUBLIN--(BUSINESS WIRE)--The "Global Process Analytical Technology Market, by Technology (Spectroscopy, Chromatography), Measurement (On-line, In-line, At-line ...