As the standard in pharmaceutical development, the Quality by Design principle (QbD/ICHQ8) – based on guidelines developed by the International Conference of Harmonisation (ICH) – states that quality should be built into a product. The approach lets you anticipate potential quality issues during production, increase the product quality assurance level, realise efficient production and cost reduction, and make regulatory oversight more efficient.
On its own the QbD/ICHQ8 approach doesn’t give companies a concrete methodology adapted to their specific situation. That’s why we offer SMART QbD, a proven and comprehensive step-by-step methodology to assist companies during the implementation of their QbD/ICHQ8 projects. SMART QbD is based on the well-known Six Sigma project management tool that is used to improve the quality of the output of processes. It uses various quality management methods to identify and remove causes of defects within a manufacturing process. With the Six Sigma framework, companies are able to save time, reduce costs and improve processes continuously.
SMART QbD focuses on specific client needs. It adapts to project goals and constraints in different situations, including the development of a new drug or substance and the redesign or optimisation of unit operations, or even of full industrial processes.
SMART QbD applies statistics to data to increase product and process knowledge to ensure you make the right decisions. Previous knowledge or test data is analysed with the most suitable statistical tool, to reveal key information anticipating future trials and Design of Experiment (DoE).
SMART QbD focuses on attaining project goals with the DMAIC (Six Sigma) project management tool. A Project Charter defines objectives, resources and constraints. An ROI statement can be prepared to assess the project financially.
SMART QbD includes a range of risk analysis tools adapted to different development processes and stages, including pre-DoE, post-DoE, and pre-validation. The tools define re-usable ‘platform’ unit operation templates on the basis of prior knowledge. They also simplify knowledge sharing, and reduce the need for endless risk analysis meetings.
Getting results on time is very important in the life sciences, healthcare and cosmetics industries. SMART QbD takes account of time constraints, like time-to-market goals. You save time because you don’t have to start your QbD/ICHQ8 project from scratch. You take advantage of previous knowledge or trials and define what’s missing and necessary for project goals, using advanced DoE features.