ICH guideline
ICH Q11 Q&As: Questions & Answers: Selection and Justification of Starting Materials for the Manufacture…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q11 Q&As |
|---|---|
| Title | Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | Since reaching Step 4 in 2012, worldwide experience with implementation of the ICH Q11 Guideline and its recommendations on the development and manufacture of drug substances has given rise to requests for clarification relating to the selection and justification of starting materials.The Q11 Implementation Working… |
| File | Q11 - training video (mp4) |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- Q11 - training video (mp4) 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.