ICH guideline
ICH Q11: Development and Manufacture of Drug Substances (Chemical Entities and…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q11 |
|---|---|
| Title | Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The Guideline reached Step 4 of the ICH process on 1 May 2012. This Guideline describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) Sections 3.2.S.2.2… |
| File | Q11 Training Material |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- Q11 Training Material 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.