Quality by Design, QbD, Design of experiments, DoE, critical process parameters, CPP, target product profile, proven acceptable range, PAR

Quality by Design (QbD)

We are knowledgeable of the changing regulatory landscape associated with pharmaceutical development and have a team who have worked on QbD applications and who 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 to develop a range of prototypes and to 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 reduce the number of parameters to be investigated to 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.

We firmly believe in applying a sensible, logical and scientific approach to pharmaceutical development.  We make data driven decisions and capture these and the rationale behind them in a clear manner in professionally written development reports that can be incorporated into your regulatory filing. We also understand that companies have API, budgetary and time constraints and we are forthcoming with advice and guidance on what we believe to be the most suitable programme of work for a given project.

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