Comprehensive Analytical Data Record for Drug Stability in Novel Packaging
This template records data from stability studies on drugs packaged in novel packaging systems, ensuring that the packaging provides adequate protection against degradation.
| Parameter | Details |
|---|---|
| Product Name | [Product Name] |
| Batch Number | [Batch Number] |
| Test Parameters |
– Assay – Degradation Products  – Appearance – Mechanical Stability |
| Storage Conditions | [e.g., 25°C/60% RH, 40°C/75% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Results Summary | [Summarize key findings at each interval] |
| Signatories | QA, QC, Packaging Specialist, Regulatory Affairs |