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 ...

Reframing pharmaceutical production around process stability, real-time quality assurance, and regulatory alignment in the ...

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

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

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 ...

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

Raman Spectroscopy is an optical spectroscopy technique that provides a molecular fingerprint of a sample. Used as a practical analysis technique used inside and outside of the laboratory, Raman ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

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

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 ...

Pharmaceutical manufacturing has traditionally been performed using batch process techniques. Batch processes have been proven over many decades of use, but can have shortcomings when it comes to ...