RABS / Isolator (if used) – Qualification Certificate Template

Qualification Certificate

Equipment Information

Equipment: RABS / Isolator

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

Qualification Flags

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Qualification Details

Equipment Identifier: [Equipment Identifier]

Protocol References: [Protocol References]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary

[Deviations Summary Line]

Overall Qualification Statement

The RABS / Isolator equipment has been successfully qualified for use in the production of sterile eye drops and eye ointments, meeting all regulatory and quality standards.

Approvals

Approved By: [Approvals]

Next Due Date

Requalification Due: [Next Due Date]

See also  Sigma Mixer / Kneader – OQ Protocol