QbD (Quality by Design) is a systematic pharmaceutical development concept that emphasizes designing the quality of the product throughout the entire drug development and production process. It involves considering the quality of the final product from the very beginning of the development phase. Based on existing experience and risk assessment, in-depth research should be conducted on various aspects such as material selection, formulation design, determination of process routes, and control of process parameters. Although the development process becomes more complex, the advantages brought by the QbD approach are evident. These advantages include reducing quality risks, improving the predictability and controllability of the production process, accelerating the time to market, and enhancing the product’s competitiveness.
Medicilon Cloud Lecture Hall invites Dr. Binbin Liu to share his practical experience and insights on applying the QbD concept in pharmaceutical formulation development. Let’s take a look at Dr. Liu’s Q&A session.
Pharmaceutical preparation
Q: What is the current attitude of the China CDE towards the application of QbD in drug development submissions?
Dr. Liu: During the live broadcast, I briefly introduced the application of QbD in drug development and the attitudes and perspectives of regulators from both China and overseas during the subsequent submission process. In the US and Europe, they are clearly supportive of the application of QbD. Although China does not currently mandate the implementation of QbD in new drug development and submissions, China has shown a commitment to international standards by joining the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) in 2017. I believe that in the future, we will undoubtedly move towards aligning with international standards. Therefore, it can be assured that the application of QbD in the new drug development submission process in China will be positively received.
Q: When conducting DoE (Design of Experiments), what is the difference between the design space and the operating space?
Dr. Liu: The design space includes all variable combinations of formulations or process parameters that ensure meeting the product quality requirements. However, at the edges of the design space, there may be the possibility of impacts on product quality, as some unnoticed fluctuations could potentially have an effect. Therefore, we need to further define the design space by delineating a smaller range within it, known as the operating space or control space, to ensure product quality to a greater extent. Within this smaller range, we can ensure product quality even if there are variations in the variables. In other words, the design space is larger than the operating space, and the operating space carries less risk, ensuring product quality more rigorously compared to the design space.
Q: Has Medicilon already applied the QbD concept in its product development for drug development?
Dr. Liu: Currently, Medicilon is applying the QbD concept in both its new drug and generic drug projects for drug development, but there are differences in the extent of its application. Some projects fully implement the QbD concept, while others may not fully adopt QbD and DoE designs for detailed research due to time constraints or because deeper understanding is not immediately necessary at that stage. Nevertheless, concepts related to QbD, such as defining target product quality profiles and conducting risk assessments, are applied in nearly all projects. Additionally, we have extensive experience in QbD. Whenever there is a demand from clients, we can fully implement the QbD concept tailored to their products.
