Q B D stands for Quality by Design. It is a concept used in various industries, particularly in pharmaceutical manufacturing, to ensure the quality of a product or process is emphasized from its inception and throughout its life-cycle. Q B D involves proactive strategies and approaches that are employed to design and optimize quality into a product or process, rather than relying solely on testing and inspection at the end.
The main objective of Q B D is to understand and quantify the impact of each input parameter, manufacturing process, and environmental condition on the quality attributes of a product. By systematically identifying and controlling critical parameters, Q B D aims to reduce variability and improve quality, safety, and efficacy.
The Q B D approach is characterized by six essential steps: (1) defining the quality target product profile, (2) identifying critical quality attributes, (3) determining the most critical process parameters, (4) establishing a design space, (5) developing a control strategy, and (6) continuously monitoring and improving the process.
By implementing Q B D principles, organizations can enhance product quality, reduce manufacturing risks, improve efficiency, and increase patient safety and satisfaction. Q B D has gained widespread adoption in the pharmaceutical industry due to regulatory encouragement and its efficacy in achieving consistent quality.
