1 / 4

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.

Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

More Related