ICH guideline
ICH Q3B(R2): Impurities in New Drug Products
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q3B(R2) |
|---|---|
| Title | Impurities in New Drug Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This Guideline has been first revised and finalised under Step 4 in February 2003. It complements the Guideline on impurities in new drug substances and provides advice in regard to impurities in products containing new, chemically synthesized drug substances. The Guideline specifically deals with those impurities… |
| File | Q3B(R2) Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q3B(R2) Guideline 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.