Focused on your specific needs.
SMART QbD™ adapts to the project goals and constraints in different situations:
- New drug product or substance full development.
- Generic pharmaceutical development.
- Redesign and /or optimisation of unit operations or full industrial process (legacy products).
Focused on data.
SMART QbD™ applies statistics to your data to increase product and process knowledge and to take the right decisions .
- It is not necessary to start from scratch. All previous knowledge/testing is valuable and can be treated with the most suited statistical tool to reveal key information in order to reduce and orient future trials and DoE.
- SMART QbD uses the most know statistical packages for uni-multivariable studies and Design of Experiments to define Design Space.
Focused on attaining project goals.
SMART QbD™ includes project management tool DMAIC (Six Sigma) specially adapted to QbD projects. A Project Charter defines objectives, resources and constraints. If necessary a ROI statement can be prepared to assess the project financially.
- Business Case definition.
- Black Belt consultant perform Project Management following DMAIC cycle and acts as a facilitator with the development team to guide project milestones.
Focused on what is relevant.
SMART QbD™ includes Risk Analysis tools adapted to the different stages during development: pre-DoE, post-DoE, pre-validation etc.
- RA tool uses previous knowledge to define “platform” unit operation templates that are re-usable. This is a key feature to save time for future similar projects.
- RA tool is designed to be collaborative to ease knowledge sharing and to reduce the need for endless RA meetings.
- The outputs of RA work are available for the team to review and update.
Focused on getting results on-time.
SMART QbD™ is taking into account time constraints, that sometimes is time to market goals, in different ways:
- Taking advantage of previous knowledge/trials.
- Defining what is missing (and necessary) for project goals.
- Using Design of Experiments advanced features to minimise the number of trials: D-optimal designs, definitive screening designs etc.