ICH guideline
ICH Q1 EWG: Stability Testing of Drug Substances and Drug Products
ICH guideline · Quality Guidelines · Step 3
Key facts
| ICH code | Q1 EWG |
|---|---|
| Title | Stability Testing of Drug Substances and Drug Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 3 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2021. Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:Streamlining the series, combining the… |
| File | Q1 Step 2 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q1 Step 2 Presentation Files published by ICH
- None 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.