Qualification Execution Checklist

Equipment: Lyophilizer Vacuum System

Subcategory: Sterile Powders & Lyophilized Products

Area: Production

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

CSV Required: Yes

Pre-start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive maintenance completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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