Comprehensive Stability Study Protocol for Freeze-Dried Products
This protocol outlines the procedures for conducting stability studies on freeze-dried products, focusing on reconstitution time, potency, and appearance changes under different storage conditions.
| Parameter | Details |
|---|---|
| Product Name | [Freeze-Dried Product Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of freeze-dried products under various environmental conditions. |
| Test Parameters |
– Appearance – Reconstitution Time  – Degradation Products |
| Storage Conditions | [e.g., 2-8°C, 25°C/60% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant change in reconstitution time or potency. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |