«Quality by design» means designing and developing a product and related entire process in order to ensure that product consistently attains a predefined quality level during all phases.
Quality by design: How create it?
A great interaction between different functions (Operation, Quality, Engineering and Sterility team) is required since first step of a new project in order to evaluate all points of view and find an acceptable compromise to assure quality of entire process.
Risk management process
Periodic re-evaluation must be executed (to confirm if your mitigation plan are still valid) or in case of change (to evaluate if different actions must be implemented to support your control strategy)
Quality by design: example of systems implemented in our experience (RABS)
- Specific training plan implemented for personnel involved in activities inside aseptic area ( gowning – cleaning – behaviours )
- Control training compliance before access into aseptic area
- Automatic control of cleaning state of RABS/Filling room before start with machine assembly
- Automatic control of sterile status of machine parts before assembly
- Intervention management within a specific system
- Automatic stop of filling machine in case of particles level non conform
- Automatic discard of machine in case of specific intervention