Qualification Execution Checklist for Distillation Unit

API Manufacturing (Chemical Synthesis & Purification)

Pre-start Checks

Training completed
SOPs approved
User Requirements Specification (URS) approved
Risk Assessment (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed