Qualification Certificate
Equipment: Depyrogenation Tunnel / Dry Heat Sterilizer (Glass Bottles)
Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)
Area: Production
| Qualification Type | Status |
|---|---|
| Design Qualification (DQ) | Yes |
| Installation Qualification (IQ) | Yes |
| Operational Qualification (OQ) | Yes |
| Performance Qualification (PQ) | Yes |
Equipment Identifiers: [Insert Equipment ID]
Protocol References: [Insert Protocol Ref]
Execution Dates: [Insert Execution Dates]
Calibration Status: [Insert Calibration Status]
Deviations Summary: [Insert Deviations Summary]
Overall Qualification Statement
The Depyrogenation Tunnel / Dry Heat Sterilizer has been qualified in accordance with regulatory standards and is deemed suitable for use in the production of sterile ophthalmic products.
Approvals
[Insert Approval Signatures]
Next Due Date
[Insert Next Due Date]