Inline Heater / Heat Exchanger – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Inline Heater / Heat Exchanger

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

Area: Production

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

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance completed

Protocol Readiness and Approvals

Protocol drafted
Protocol approved by QA

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained