ICH guideline
ICH Q3A(R2): Impurities in New Drug Substances
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q3A(R2) |
|---|---|
| Title | Impurities in New Drug Substances |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | First recommended for adoption at Step 4 of the ICH Process on 30 March 1995, the Guideline was revised under Step 2 of the ICH Process on 7 October 1999 and finalised under Step 4 on 7 February 2002 (Q3A(R1)). The Guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities… |
| File | Q3A(R2) Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q3A(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.