In nearly all regions and industries, markets for products reflect the impact of globalization. The tactic of competing on price is increasingly giving way to a wider range of factors—including ...

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations. Individuals working in pharmaceutical sterile ...

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance. The quality-by-design (QbD) initiative, which focuses on building ...

The past decade has seen unparalleled growth in the field of cell therapy, which uses cells as therapeutic agents to treat and cure disease. Although the first transplants of blood stem cells date ...

Across the full range of semiconductor device types and design nodes, there is a drive to produce chips with significantly higher quality. Automotive, IoT and other industrial applications require ...

Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...