Qualification Certificate

Equipment: CCIT System (Vacuum Decay/HVLD)

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: QC/Production

DQ/IQ/OQ/PQ Flags: Yes / Yes / Yes / Yes

Requalification Frequency: 12 Months

Equipment Identifiers

Serial Number: [Serial Number]

Model Number: [Model Number]

Protocol References

Protocol Number: [Protocol Number]

Execution Dates

Installation Qualification (IQ) Date: [IQ Date]

Operational Qualification (OQ) Date: [OQ Date]

Performance Qualification (PQ) Date: [PQ Date]

Calibration Status

Calibration Status: [Calibration Status]

Deviations Summary

Summary of Deviations: [Deviations Summary]

Overall Qualification Statement

Based on the executed qualification protocols, the CCIT System has been found to be compliant with the specified requirements and is deemed qualified for use in the QC/Production area.

Approvals

Qualified By: [Qualified By]

Approved By: [Approved By]

Next Due Date

Next Due Date for Requalification: [Next Due Date]