Qualification Execution Checklist

Equipment: Leak Test Machine (Bottle)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production/QC

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

CSV Required: Yes

Pre-Start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM schedule adhered to

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed