ICH guideline
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q1A(R2) |
|---|---|
| Title | Stability Testing of New Drug Substances and Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This Guideline has been revised a second time and has reached Step 4 of the ICH process in February 2003. This Guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration for Climatic Zone I and II. Furthermore, the revised document takes into account the… |
| File | Q1A(R2) Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q1A(R2) Guideline 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.