Quality by Design
Keeping Pace with the Changing Regulatory Landscape
Our team has in-depth experience with Quality by Design (QbD) applications and are experienced at interacting with regulatory authorities on this topic. We have incorporated the principles of ICHQ8, ICHQ9 and ICHQ10 into our quality system, and have developed internal guidelines on how to apply these to development projects.
When developing a commercial formulation, we use the Target Product Profile and Critical Quality Attributes (CQAs) identified by the client. This enables us to develop a range of prototypes and investigate a range of manufacturing processes. Once a lead formulation and manufacturing process is identified, our experts use formal risk assessment tools to identify all possible Critical Processing Parameters (CPPs). We use paper screening and lower resolution Design of Experiment (DoE) to ensure the number of parameters to be investigated is at a practical and sensible level. We then apply a more powerful DoE with higher resolution to generate more powerful data, which results in a clear understanding of the manufacturing process and which parameters have the most effect on CQAs.
Applying a Sensible, Logical and Scientific Approach
We make data driven decisions, capturing them (and the rationale behind them) in clear and professionally written development reports, which can be incorporated into your regulatory filing. We understand that companies have API, budgetary and time constraints and we can offer advice and guidance on what we believe to be the most suitable program of work for you.