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


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