Comprehensive Stability Study Protocol for Drug Products in Extreme Environmental Conditions
This protocol outlines the procedures for conducting stability studies on drug products exposed to extreme environmental conditions, such as high heat, cold, and humidity. The study assesses physical integrity, potency, and microbial stability.
| Parameter | Details |
|---|---|
| Product Name | [Product Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of drug products under extreme environmental conditions. |
| Test Parameters |
– Assay – Physical  – Degradation Products – Microbial Stability |
| Extreme Conditions | [e.g., 40°C/75% RH, -20°C] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in physical integrity, potency, or microbial stability. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |