ICH guideline
ICH Q9(R1): Quality Risk Management
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q9(R1) |
|---|---|
| Title | Quality Risk Management |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Q9(R1) Guideline reached Step 4 of the ICH process on 18 January 2023. The ICH Q9(R1) Quality Risk Management Guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality and make limited and… |
| File | ICH Q9(R1) Training Materials |
| File type | Zip |
| File on ich.org | database.ich.org |
At a glance
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- ICH Q9(R1) Training Materials Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.