Learn more about Quality by Design principles and how they can be applied in drug product development to bring better biologics to patients faster. Quality by Design (QbD) has transformed the approach ...

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ ...

When developing medical device products and the parts that comprise them, engineers must usually decide what elements of the design are critical to function and, therefore, what dimensions require ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...