ICH Published revised Q9 Guidance as Ver (R1) on 18-Jan-2023. This presentation is aimed at understanding this revised version specifically with reference to the changes.
A detailed full explanation of concepts of Quality Risk management with practical example can be visited at:
This revised version specifically has 4 major changes as below:
1. Formality in QRM approach
2. Risk based decision making
3. Minimizing subjectivity
4. Evaluation of risk related to Product availability & supply chain
The tools of risk assessment like Failure mode effect analysis (FMEA), Failure mode effect & criticality analysis (FMECA), HACCP remains the same.
This version also considers details related to State of control of manufacturing process, controls related to facility and equipment as well as control of outsourced activities.
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Негізгі бет Revised ICH Q9 (R1) Quality Risk Management Guideline | Jan 2023
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