What is the Origin of Quality by Design (QbD)?

The concept of QbD was initially formalized and promoted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in the early 2000s, specifically in their Q8 guideline. The philosophy is a direct evolution from earlier industrial quality management systems, adapted for the rigorous demands of pharmaceutical chemistry and manufacturing. It represents a paradigm shift toward proactive quality assurance.

What is the Mechanism of Quality by Design (QbD)?

Implementing QbD involves defining a target product profile, identifying the CQAs, and then establishing a design space that defines the acceptable operating range for the manufacturing process. Risk assessment tools are systematically used to identify and control potential sources of variability in raw materials and processes. By controlling the input variables within the established design space, manufacturers can ensure the resulting hormonal product consistently meets its pre-defined quality specifications.

Quality by Design (QbD)

Meaning

Quality by Design, or QbD, is a systematic, science-based approach to pharmaceutical development and manufacturing that focuses on building quality into a product from the very beginning. Instead of relying solely on end-product testing, QbD emphasizes a thorough understanding of the critical quality attributes (CQAs) of the drug product and the critical process parameters (CPPs) that influence them. This approach is highly relevant in the compounding of hormonal and peptide therapies to ensure batch-to-batch consistency and patient safety.