Quality by Design

Quality by Design (QbD) is a systematic approach to the development of a drug with a focus on product and process understanding and process control, based on sound science and quality risk management. Adopting a QbD framework for your process and product development will deliver consistency, robustness and increased process knowledge.

PMCC offers consultancy in all aspects of the implementation of QbD including setting the quality target product profile, identifying critical and key quality attributes, material attributes and process parameters, performing risk assessments and developing and managing control strategies. With our QbD consultancy we generally aim to coach clients through the process so they learn the skills and are able implement this independently going forward. However, we are also happy to be involved in whatever way suits the client and the project.