ICH guideline
ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q13 |
|---|---|
| Title | Continuous Manufacturing of Drug Substances and Drug Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Q13 Guideline reached Step 4 of the ICH process on 16 November 2022.The guideline:Builds on existing ICH Quality Guidelines, provides clarification on continuous manufacturing (CM) concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug… |
| File | Q13 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q13 Step 4 Presentation, Q13 Module 12 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.