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 ...

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 ...

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

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 ...

Picarro Inc., a global leader in high-precision gas concentration analytical solutions, today announced the launch of the PI212 ...

Design space optimization and flexibility analysis are central to enhancing the robustness, efficiency and regulatory compliance of pharmaceutical manufacturing. These approaches routinely combine ...

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 ...

Gone are the days when pharmaceutical manufacturing facilities had relied on developing the same product year after year. Targeted therapies that need to be manufactured in smaller volumes for smaller ...

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

BOCA RATON, Fla.--(BUSINESS WIRE)--LGM Pharma today announced that it has acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. The combination ...

To guarantee the safety and efficacy of products manufactured in cleanroom environments, organizations such as International Organization for Standardization (ISO) and regulatory bodies such as the ...