Qualification Certificate
Equipment: Aseptic Filling Machine (IV Bags)
Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)
Area: Production
| Equipment Identifier | [Equipment Identifier] |
|---|---|
| Protocol Reference | [Protocol Reference] |
| Execution Date | [Execution Date] |
| Calibration Status | [Calibration Status] |
| Deviations Summary | [Deviations Summary] |
| Overall Qualification Statement | The Aseptic Filling Machine (IV Bags) has been successfully qualified in accordance with established protocols and meets all regulatory requirements. |
| Approvals | [Approvals] |
| Next Due Date | [Next Due Date] |
Qualification Flags
- Design Qualification (DQ): Yes
- Installation Qualification (IQ): Yes
- Operational Qualification (OQ): Yes
- Performance Qualification (PQ): Yes
Requalification Frequency
12 Months