News & Media

Quality By Design: come costruire l’analisi del rischio?

03 Marzo 2017 News

Patrizia Muscas, Sterility Assurance Manager Eli Lilly
Speaker a Clean Room & Sterility Assurance 2017

 «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

quality by design
Dedicated risk assessment must be put in place during initial qualification of a new line to establish risk level (Ex. Interventions/Gloves /Room classification)

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

Patrizia Muscas interverrà a Clean Room & Sterility Assurance dell’8 marzo 2017: guarda tutti gli interventi della giornata