Qualification Certificate
Equipment: Leak Test Machine (Bottle)
Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)
Area: Production/QC
| Equipment Identifier | [Equipment Identifier] |
|---|---|
| Protocol References | [Protocol References] |
| Execution Dates | [Execution Dates] |
| Calibration Status | [Calibration Status] |
| Deviations Summary | [Deviations Summary] |
Overall Qualification Statement
The Leak Test Machine (Bottle) has been successfully qualified in accordance with the DQ/IQ/OQ/PQ protocols. It meets the necessary requirements for the production of sterile ophthalmic products.
Approvals
Approved by: [Approver Name]
Date of Approval: [Approval Date]
Next Due Date
Next Requalification Due: [Next Due Date] (12 Months)