ABSTRACT
This chapter introduces the quality-by-design (QbD) principles to those who want to acquire a better understanding or to find out more about this subject. The traditional approach for pharmaceutical process and product development has been based on empirical experimentation rather than science and risk-based analysis. The development of nanocarriers as drug delivery systems is challenging, involving complex and nonstandard manufacturing process, which encompasses greater difficulties in the assessment of potential risks and impact of raw materials’ attributes and process parameters (PPs). The quality target product profile (QTPP) is a summary of the product quality characteristics which is defined according to the product objectives, the relevant physicochemical characteristics and the intended product performance. The critical quality attributes (CQAs) are chemical, physical or microbiological properties of the drug product which must be within an appropriate limit or range to ensure the desired product quality.
