Professional Documents
Culture Documents
Industry
Competent
Facilities Authorities
&
Equipment
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT
EFPIA. TG
dedicated facilities, 2006
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 15
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Risk Identification
and conclusions
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 17
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
incidental (cross-)contamination
Risk Identification
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
Review Events
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 18
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
- Microbiological contamination
e.g. API susceptible to microbiological growth?
- Cross-contamination Initiate
Quality Risk Managem ent
Risk Identification
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 19
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Risk Identification
Pr ocess
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 20
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Risk Identification
Pr ocess
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 21
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Risk Identification
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 22
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Risk Analysis
Risk Evaluation
- …
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 23
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Risk Identification
Pr ocess
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 24
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
> Internal:
- “GMP-Master plan” to demonstrate that
the risk management process is used
- Capital investment plan can be supported or even
changed by the quality risk management process
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 25
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
Initiate
Quality Risk Managem ent Pr ocess
Risk Identification
Risk Analysis
Risk Evaluation
una c c e pta ble
Risk Reduction
Risk Acceptance
Risk Review
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 26
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 27
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 30
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT
• Calibration/preventive maintenance
> To set appropriate calibration and maintenance schedules
• Qualification of facility/equipment/utilities
> To differentiate scope and efforts and decisions
based on the intended use
➢ multi-versus single-purpose
➢ batch versus continuous production
• Cleaning of equipment and environmental control
> To determine acceptable (specified)
cleaning validation limits
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 31
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 34
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 35
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 36
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 37
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 38
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 40
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 41
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
D: Technology approaching
obsolescence
Does the system rely on the A: Yes
Security "public internet" in the operation
of the system? B: No
W. Schumacher, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 42