Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in the ...

The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.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

Design for manufacturing (DFM) is the process of designing your product with the goal of making it easy to manufacture. It is a critical manufacturing tooling design and process development step ...

Models and modeling software gain a foothold in solid-dosage manufacturing process design. ALENGO/GETTY IMAGES; DAN WARDUsing model-predictive design to define, predict, and control a process is ...

Once upon a time, integrated circuits (ICs) were built by the same companies that designed them. The design of an IC was tightly integrated with the manufacturing processes available within each ...

For decades there have been five basic types of manufacturing processes. They are distinct. Great design engineers understand the nuances of these processes and tailor their designs accordingly. There ...

Turning 3-dimensional product models into manufacturing process designs is no easy task. Kevin Marseilles, senior process designer with Delphi Corp.’s Saginaw Steering Systems Division, used to spend ...

Design for manufacturing (DFM) refers to actions taken during the physical design stage of IC development to ensure that the design can be accurately manufactured. At larger nodes, most of the defects ...

The need for Design for Manufacture and Assembly (DFMA) began shortly after the dawn of the Industrial Revolution, but it took a hundred years for it to ultimately come into focus in the 1960s, and it ...