Qualification Execution Checklist for SIP System (Tanks/Lines)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production/Sterilization

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures followed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained