The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.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

In an effort to make your production line more efficient, look at the different ways to lay out the production line or overall manufacturing plant. Two of the most common layouts are the process ...

To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, ...

Modular, skid-mounted process equipment—such as CIP systems, bio processors, blowers and dryers, and compressors and pumps—is increasingly common. The following design recommendations will help ensure ...