Comprehensive Stability Study Protocol for Aseptic Processing Drugs
This protocol outlines the steps for evaluating the stability of drugs produced using aseptic processing techniques. It emphasizes sterility, chemical stability, and potency under controlled environmental conditions, ensuring compliance with regulatory standards for aseptic products.
| Parameter | Details |
|---|---|
| Product Name | [Aseptic Processing Drug Name] |
| Batch Number | [Batch Number] |
| Objective | To assess the long-term stability of aseptically processed drugs by evaluating sterility, potency, and physical integrity over the study period. |
| 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 appearance during the study period. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |