Revised ICH Q9 (R1) Quality Risk Management Guideline | Jan 2023

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.
Your queries:
Revised ICH Q9 guidance
ICH Q9 updated guidance
Quality Risk Assessment
Risk Management
ICH Guidelines
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ICH Guidelines for Pharmaceuticals
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[@dattatraykulkarni9353]

Best Resorceful

[@prady654]

i love the way it is presented, and would be happy to see many topics in your channel, best wishes.

[@choudharykudapa]

Nicely covered the content. Thanks alot

[@proftalks1680]

Thank you🙏

[@vijaysm7557]

It's very nice addressed

[@tusharrajput1804]

Nicely explained

[@proftalks1680]

Thank you🙏

[@pallechandramohanreddy8359]

Nice presentation

[@proftalks1680]

Thank you very much

[@sureshmolakalapalli]

Thank you sir for very good explanation, please explain with real time examples of all tools or atleast fmea with pharmaceutical production systems and qc

[@proftalks1680]

Thank you🙏... For atleast FMEA concept you can refer ICH Q9 presentation. I will surely work on suggestion for real time example

[@vijaysm7557]

Please provide an example, how the revised guidelines used in API industries

[@swapnilwalekar2926]

Well explained ,i want ppt form for this