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A small piece of thought about risk assessments

Updated: Jun 18

The new version of ICH Q9: Quality Risk Management is going to be implemented in EU in 2023-JUL-23. This version doesn't contain any big innovation on handling risks (or hazards, as it say), however, it really tries to promote to use the mindset of assessing, reducing and eliminating risks.

But this gives an opportunity to mention:

Q9 doesn't always require us to establish huge spreadsheets and RPN calculations. There are some cases when risk assessment is to think through a simple process step, and describe how the related risks can be under control - in an already available SOP or work instruction.

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