Qualification Execution Checklist for Ophthalmic Holding Tank

Equipment Details

Equipment: Ophthalmic Holding Tank (Sterile/Pressurized)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

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

CSV Required: Yes

Pre-Start Checks

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

Calibration records verified
Preventive Maintenance (PM) status confirmed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations documented and managed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed