Annex II: Potential Applications

ICH Q9 QUALITY RISK MANAGEMENT

II. 6 Quality risk management as part of…

Industry

Production Competent
Authorities

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

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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE

Integrated Quality Management Validation

Process Cleaning Support System Computer Method

Validation Validation Validations Validation Validation

Deviation Out of Specification

Failure Investigation

CAPA

Re-Validation Change Control

Periodic Review
T. Matsumura, Eisai
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT

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

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4