Comprehensive Stability Study Protocol for Complex Drug Products
This protocol outlines the procedures for conducting stability studies on complex drug products, such as combination therapies or biologics, to assess their stability under various environmental conditions.
| Parameter | Details |
|---|---|
| Product Name | [Complex Drug Product Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the stability of complex drug products under specified environmental conditions. |
| Test Parameters |
– Assay – Degradation Products  – Appearance |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in assay, degradation products, or appearance. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |