Qualification Execution Checklist for mAbs Media Preparation Vessel

Pre-start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol ready for execution
All approvals obtained

Execution Controls

Good Documentation Practice (GDP) followed
Data recording completed
Deviation log maintained

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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