1. Customer objective definition

2. QbD relevant development / organizational interfaces

3. Development Knowledge Base

• Chemical/physical identities
• Product composition and formulation
• Production processes& technology
• Reference model/ Benchmarking also covering many branches
• R & D process
• Analytical & process assessment (current)
• Process key data
• Multivariate Data analysis
• Support for design of experiements (DOE)
  
  
• Status report knowledge space mapping

1. Risk assessment
2. Risk control
3. Determination of Critical Process Parameters (CPP) and Critical Control Points (CCP)
4. Definition of verification of CCP as well as development of the corrective actions
   
   

• Design specification

1. PO Development of dynamic process control
2. 2. Composition/Conception Technical Design, …
3. 3. Piloting
4. 4. Qualification/Validation
5. 5. Realization
6. 6. Reorganization
7. 7. Training
8. 8. Monitoring

• Final acceptance
  continious improvement
  process