Qualification Execution Checklist

Equipment: High Pressure Reactor / Hydrogenator

Subcategory: API Manufacturing (Chemical Synthesis & Purification)

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
PM schedule adhered to

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

GDP followed
Data recording procedures in place
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained