Qualification Execution Checklist

Equipment: Sterilizing Autoclave (Components)

Subcategory: Ophthalmics (Sterile Eye Drops/Eye Ointments)

Area: Production

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM completed

Protocol Readiness and Approvals

Protocol drafted
Protocol approved

Execution Controls

GDP followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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