Quality by Design (QbD) is a strategic approach employed in various industries, including pharmaceuticals, manufacturing, and product development, to ensure the consistent delivery of high-quality products. It involves a systematic and proactive process of integrating quality considerations throughout the entire product lifecycle, from conception to production.
In the context of pharmaceuticals, Quality by Design focuses on optimizing the development, manufacturing, and control processes of drugs to enhance their safety, efficacy, and overall quality. It requires a deep understanding of the product's critical quality attributes (CQAs), which are the measurable characteristics that determine its performance, and the critical process parameters (CPPs), which are the variables affecting the manufacturing process.
The core principle of Quality by Design is to identify and understand the relationships between the product's CQAs and the CPPs that influence them. This knowledge is gained through a combination of scientific experimentation, risk assessment, and statistical analysis. By thoroughly studying these relationships, manufacturers can establish a design space within which the product can consistently meet the desired quality standards.