Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

Regulating manufacturing processes in the medical device industry is challenging. But process signature verification can help manufacturers get a handle on problems before they get out of control.

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 ...

Even after 20 years or so, process control continues to be a confusing or misunderstood technology. A short description of process control is an accurate one—It’s a means of controlling manufacturing ...

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

Manufacturing is getting a lot more attention in the news recently. While globalization has pushed the availability of goods around the world and lowered their cost in significant ways over these past ...