ICH guideline
ICH Q3E EWG: Guideline for Extractables and Leachables
ICH guideline · Quality Guidelines · Step 3
Key facts
| ICH code | Q3E EWG |
|---|---|
| Title | Guideline for Extractables and Leachables |
| Guideline series | Quality Guidelines |
| ICH step | Step 3 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2019. Further to the MC's endorsement of the Q3E Concept Paper and Business Plan in July 2020, the Q3E EWG was established to work on the development of the Q3E Guideline on the assessment and control of extractables and leachables (E&L), and is expected would assist… |
| File | ICH Q3E Step 2 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- ICH Q3E 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.