Annex II: Potential Applications prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT II. 6 Quality risk management as part of… Production Competent Authorities Industry

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

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

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