ICH guideline
ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q6B |
|---|---|
| Title | Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in March 1999. This document provides general principles on the setting and justification of a uniform set of international specifications for proteins and polypeptides which are produced from recombinant or non-recombinant cell-culture expression systems. The… |
| File | Q6B Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- Q6B 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.