DOI: 10.36347/sajp

Pages: 324-330

Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy by implementing quality by design (QbD), a science based approach that improves process understanding by reducing process variation and the enabling process control strategies. This review presents a detailed summary illustrating how inhalation products development can be established by implementing quality by design (QBD). A QbD development involves risk assessment, designing of experiments and multivariate statistical tools to assemble a product and process design space and linking of critical parameters to the product safety and efficacy. It is important to begin by understanding the factors like active, excipients, formulation, container closure systems, and process variables, and how these factors affect the critical quality attributes and therefore the finished product’s performance within the design space. QBD intends to identify quality target product profile (QTPP), critical quality attributes (CQA), critical process parameters and quality risk assessment.