Comprehensive Stability Study Protocol for Ophthalmic Ointments
This protocol outlines the procedures for conducting stability studies on ophthalmic ointments, assessing physical, chemical, and microbial stability over time under different environmental conditions.
| Parameter | Details |
|---|---|
| Product Name | [Ophthalmic Ointment Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of ophthalmic ointments under specified conditions. |
| Test Parameters |
– Viscosity – Assay  – Appearance |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6, 12 months, etc.] |
| Acceptance Criteria | No significant changes in viscosity, microbial limits, or physical appearance. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |