ICH guideline
ICH Q14: Analytical Procedure Development
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q14 |
|---|---|
| Title | Analytical Procedure Development |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. The Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development. Q14 Analytical Procedure Development GuidelineThe new guideline harmonises the scientific approaches of Analytical Procedure Development and… |
| File | Q2(R2)/Q14 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q2(R2)/Q14 Step 4 Presentation Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.