Pharmaceutical Quality by Design

Quality by Design (QBD) is evolving and gaining importance in the pharmaceutical industry. More and more companies are experimenting with the concept and developing mechanisms to support it. This review article tries to realise and understand this ongoing concept. Critical material and process parameters are linked to the critical quality attributes of the product. A design space is the result of the study of CPPs and CQAs. With the creation of a design space, which is approved by the regulation, any small to moderate changes in the manufacturing conditions within the design space will not need to go through another regulatory submission. Risk management helps to better understand the risks, ways to mitigate them and control strategy is proposed commensurate with the level of the risk. This article explains the process of risk management as defined by ICH Q9. QbD is the future of product and process improvement, and as such leads to continuous improvement and innovation in products and processes.