Qualification Certificate
Equipment: Prefilled Syringe Washing Machine
Subcategory: Prefilled Syringes & Cartridges
Area: Production
| Qualification Type | Status |
|---|---|
| Design Qualification (DQ) | Yes |
| Installation Qualification (IQ) | Yes |
| Operational Qualification (OQ) | Yes |
| Performance Qualification (PQ) | Yes |
Equipment Identifiers:
Serial Number: [Insert Serial Number]
Model Number: [Insert Model Number]
Protocol References:
DQ Protocol: [Insert DQ Protocol Reference]
IQ Protocol: [Insert IQ Protocol Reference]
OQ Protocol: [Insert OQ Protocol Reference]
PQ Protocol: [Insert PQ Protocol Reference]
Execution Dates:
DQ Execution Date: [Insert DQ Execution Date]
IQ Execution Date: [Insert IQ Execution Date]
OQ Execution Date: [Insert OQ Execution Date]
PQ Execution Date: [Insert PQ Execution Date]
Calibration Status:
Calibration Status: [Insert Calibration Status]
Deviations Summary:
[Insert Deviations Summary]
Overall Qualification Statement:
The Prefilled Syringe Washing Machine has been successfully qualified in accordance with the applicable protocols and regulatory requirements.
Approvals:
Qualified by: [Insert Qualified By]
Approved by: [Insert Approved By]
Next Due Date:
Next Requalification Due Date: [Insert Next Due Date]