ICH guideline
ICH Q5D: Derivation and Characterisation of Cell Substrates Used for Production of…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q5D |
|---|---|
| Title | Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells used to prepare biotechnological/biological products, and for the preparation and characterisation of cell banks to… |
| File | Q5D Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q5D 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.