Quality by Design (QbD)

Quality by Design is the outcome of applying PAT principles right and deeply from process development throughout the entire life cycle of a product. Is both on of the earliest/oldest concepts of the entire effort of bringing innovation into pharmaceutical and biologics manufacturing at the onset of XXI century. That change was brought about first by the US FDA and then followed by Guidelines from ICH that contained the concepts of QbD and Design Space. All those concepts are tightly related to DOE, multivariate modeling and depend on a well rooted PAT program at a company.

In a Quality-by-Design system:

• The product is designed to meet patient requirements
• The process is designed to consistently meet product critical quality attributes
• The impact of formulation components and process parameters on product quality is understood
• Critical sources of process variability are identified and controlled
• The process is continually monitored and updated to assure consistent quality over time

The first rule of any technology used in a business is that automation applied to an efficient operation will magnify the efficiency. The second is that automation applied to an inefficient operation will magnify the inefficiency.”

Bill Gates