Qualification Execution Checklist for Stoppering Machine (Bottle Line)

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Pre-start

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Affairs (RA) approval obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol finalized
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed