Qualification Certificate

Equipment Details

Equipment Name: Dropper/Tip Insertion Machine

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

Qualification Flags

Design Qualification (DQ): Yes
Installation Qualification (IQ): Yes
Operational Qualification (OQ): Yes
Performance Qualification (PQ): Yes

Qualification Protocol References

Protocol Reference: [Insert Protocol Reference]

Execution Dates

Execution Date: [Insert Execution Date]

Calibration Status

Calibration Status: [Insert Calibration Status]

Deviations Summary

Deviations Summary: [Insert Deviations Summary]

Overall Qualification Statement

The Dropper/Tip Insertion Machine has been successfully qualified for use in the production of sterile eye drops and eye ointments, meeting all specified requirements.

Approvals

Approved By: [Insert Approver’s Name]

Approval Date: [Insert Approval Date]

Next Due Date

Next Requalification Due Date: [Insert Next Due Date (12M)]