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 ...

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 ...

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 ...

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 ...

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 ...

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.

Opportunities in automation, biopharmaceutical production expansion, and regional investment shifts drive demand for advanced ...

According to MarketsandMarkets™, the global pharmaceutical manufacturing equipment market is projected to reach USD 21.24 ...