StabilityStudies.in
Comprehensive Stability Study Protocol for Drug Products
This protocol outlines the procedures for conducting stability studies to evaluate the shelf life of drug products under specified conditions. The study assesses physical, chemical, biological, and microbiological properties of the drug over time.
| Parameter | Details |
|---|---|
| Product Name | [Drug Product Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of the drug product under specified environmental conditions. |
| Test Parameters |
– Assay – Appearance  – Degradation Products – Dissolution – Microbial Limits |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6, 12 months, etc.] |
| Acceptance Criteria | [Define the acceptance criteria for stability testing] |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |
StabilityStudies.in