ICH guideline
ICH Q2(R2): Validation of Analytical Procedures
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q2(R2) |
|---|---|
| Title | Validation of Analytical Procedures |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Q2(R2) revised Guideline Step 4 of the ICH process on 1 November 2023. The Q2(R2) EWG revised the ICH Q2(R1) Guideline on Validation of Analytical Procedures. Q2(R1) RevisionThe scope of the revision of ICH Q2(R1) includes validation principles that cover analytical use of spectroscopic or spectrometry data… |
| File | Q2(R2)/Q14 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- Q2(R2)/Q14 Step 4 Presentation 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.