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 ...

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

Healthcare costs have surpassed $5 trillion in the United States and are increasing at approximately 8% annually, reinforcing the need for more streamlined and reliable systems that can support both ...

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 ...

A closer look at how robotics is reshaping pharmaceutical manufacturing, from improving quality and compliance to enabling more scalable production, and where the technology is headed next.

Granulation is a critical unit operation in pharmaceutical manufacturing, where fine powders are agglomerated into granules to improve flow properties, uniformity, and compaction performance. The ...

AI is revolutionizing drug discovery and manufacturing, enabling faster molecule design and predictive maintenance, enhancing quality and efficiency. Regulatory challenges and legacy systems impede ...

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 ...

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

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 ...