Comprehensive Stability Study Protocol for Sterile Products
This protocol provides a structured approach for conducting stability studies on sterile products. It focuses on key parameters such as sterility, potency, and physical integrity over time, ensuring that products remain effective and safe for use under various environmental conditions.
| Parameter | Details |
|---|---|
| Product Name | [Sterile Product Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of sterile products by monitoring key quality attributes such as sterility and potency under specified environmental conditions. |
| Test Parameters |
– Sterility  – Physical Appearance – Degradation Products |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, 12 months, etc.] |
| Acceptance Criteria | No significant changes in sterility, potency, or physical appearance throughout the study period. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |