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

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

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

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