ICH guideline
ICH Q1C: Stability Testing for New Dosage Forms
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q1C |
|---|---|
| Title | Stability Testing for New Dosage Forms |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 1996. It extends the main stability Guideline for new formulations of already approved medicines, and defines the circumstances under which reduced stability data can be accepted. |
| File | Q1C Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q1C Guideline 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.