Comprehensive Stability Study Protocol for Temperature-Sensitive Biologics
This protocol outlines the procedures for conducting stability studies on biologic products that are highly sensitive to temperature variations. The study focuses on biological activity retention, degradation, and physical changes over time under controlled storage conditions.
| Parameter | Details |
|---|---|
| Product Name | [Temperature-Sensitive Biologic Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of temperature-sensitive biologics under controlled environmental conditions. |
| Test Parameters |
– Biological Activity – Degradation  – Physical Integrity |
| Storage Conditions | [e.g., 2-8°C, -20°C] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant loss of biological activity or physical integrity. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |