Quality by Design (QbD) is a systemic approach that STEREOKEM implements to designing and developing manufacturing processes to ensure predefined product quality. The concept is that quality is built into the product with a thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. Some of the QbD elements include:

• Defining target product quality profile
• Designing product and manufacturing processes
• Identifying critical quality attributes, process parameters, and sources of variability
• Controlling manufacturing processes to produce consistent quality over time