Qualification Certificate

Equipment Details

Equipment: Leak Test Machine (Bag – Pressure/Vacuum)

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Production/QC

Qualification Status

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Requalification Frequency: 12 Months

Execution Details

Equipment Identifier: [Equipment Identifier]

Protocol Reference: [Protocol Reference]

Execution Date: [Execution Date]

Calibration Status: [Calibration Status]

Deviations Summary

[Deviations Summary Line]

Overall Qualification Statement

The Leak Test Machine has been successfully qualified in accordance with the applicable protocols and regulatory requirements.

Approvals

Approved By: [Approver Name]

Approval Date: [Approval Date]

Next Due Date

Next Due Date: [Next Due Date]