ICH guideline
ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q5C |
|---|---|
| Title | Quality of Biotechnological Products: Stability Testing 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 November 1995. This document augments the stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or… |
| File | Q5C Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- Q5C 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.