ICH guideline
ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q6A |
|---|---|
| Title | Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in October 1999. This document provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them, which have not been… |
| File | ICH Q6A Decision Tree |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- ICH Q6A Decision Tree Files published by ICH
- 1–9 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.