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Quality Risk Management in Production Industry: Validation, Monitoring, and Process Control

Explore the use of Quality Risk Management in production industries for validation, monitoring, and process control activities. Learn about analytical methods, equipment, cleaning methods, and more. Understand the importance of distinguishing between critical and non-critical process steps for effective validation studies. Discover how in-process sampling, testing, and the use of Process Analytical Technologies (PAT) can improve production planning.

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Quality Risk Management in Production Industry: Validation, Monitoring, and Process Control

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

  2. II.6: QRM as part of production • Validation • To identify the scope and extentof verification, qualification and validation activities • Analytical methods • Processes • Equipment • Cleaning methods • To determine the extent forfollow-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. EXAMPLE Validation Process Validation Cleaning Validation Support System Validations Computer Validation Method Validation Deviation Out of Specification Failure Investigation CAPA Change Control Re-Validation Periodic Review Integrated Quality Management T. Matsumura, Eisai

  4. II.6: QRM as part of production • In-process sampling & testing • Evaluate the frequency and extentof 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 timerelease • Production planning • To determine appropriate production planning • Dedicated • Campaign or concurrent production process sequences ICH Q9

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