Qualification Certificate

Equipment Information

Equipment: Inline Particle Size Analyzer (PAT)

Subcategory: NDDS – Long-Acting Injectables (Depot Suspensions)

Area: Instrument

Qualification Flags

DQ: Critical/Yes

IQ: Yes

OQ: Yes

PQ: Yes

Requalification Information

Requalification Frequency: Yes

Protocol References

Protocol Reference: [Insert Protocol Reference Here]

Execution Dates

Execution Date: [Insert Execution Date Here]

Calibration Status

Calibration Status: [Insert Calibration Status Here]

Deviations Summary

Deviations Summary: [Insert Deviations Summary Here]

Overall Qualification Statement

Overall Qualification Statement: The Inline Particle Size Analyzer has been qualified according to the established protocols and is deemed suitable for use in the specified area.

Approvals

Approved By: [Insert Approver’s Name Here]

Next Due Date

Next Due Date: [Insert Next Due Date Here]