ICH guideline
ICH Q3D(R3) Maintenance: Maintenance of the Guideline for Elemental Impurities
ICH guideline · Quality Guidelines
Key facts
| ICH code | Q3D(R3) Maintenance |
|---|---|
| Title | Maintenance of the Guideline for Elemental Impurities |
| Guideline series | Quality Guidelines |
| ICH summary (excerpt) | The ICH Q3D Guideline was finalised under Step 4 in November 2014. It is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for Elemental Impurities (EIs) for drug products administered by the oral, parenteral and… |
| File | Maintenance Procedure for Q3C, Q3D and M7 |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- Maintenance Procedure for Q3C, Q3D and M7 Files published by ICH
- None 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.