ICH guideline
ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q5E |
|---|---|
| Title | Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 2004.The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product.Therefore, this… |
| File | ICH Q5E Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- ICH Q5E Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.