1. II. 6 Quality risk management as part of…
Industry
Production
Competent Authorities

2. II.6: QRM as part of production
Validation
To identify the scope and extent of verification, qualification and validation activities
Analytical methods
Processes
Equipment
Cleaning methods
To determine the extent for follow-up activities
Sampling
Monitoring
Re-validation
To distinguish between critical and non-critical process steps to facilitate design of a validation study
ICH Q9

3. Integrated Quality Management
EXAMPLE
Integrated Quality Management
Process Validation
Cleaning Validation
Support System
Validations
Computer Validation
Method Validation
Deviation
Re-Validation
Change Control
CAPA
Failure Investigation
Out of Specification
Validation
Periodic Review
T. Matsumura, Eisai

4. II.6: QRM as part of production
In-process sampling & testing
Evaluate the frequency and extent of in-process control testing
Justify reduced testing under conditions of proven control
Evaluate and justify the use of Process Analytical Technologies (PAT) in conjunction with parametric and real time release
Production planning
To determine appropriate production planning
Dedicated
Campaign or concurrent production process sequences
ICH Q9